4.
pagina 1 van 1
1O.2.e
IGZ
Van:
Verzonden: dinsdag 11 augustus 2009 14:59
Aan:
_Dienstpostbus IGZ Zuidwest
Onderwerp: Telnot 20090811 Philoderm.doc
8ijlagen:
Telnot 20090811 Philoderm.doc
Graag aan melding
Ak’ast bedankt,
1O.2.e
11-08-2009
(Philoderm / Rofil) hangen.
rqk
AU(
coq
=
STAATSTOEZICHT OP DE VOLKSGEZONDHEID
Parnassusplein 5
2511 VX Den Haag
Postbus 16119
2500 DC Den Haag
(070) 340 79 1 1
(070) 340
WWWIgZfll
Beekadm
Ptd,m
TeIlon
nrm,
INSPECTIE VOOR DE GEZONDHEIDSZORG
Gegevens beller
Naam
1O.2.e;I1O.2.
Functie
Object
1
Locatie
Telefoonnummer
Faxnummer
E-mail adres
Inhoud
Datum en
11 augustus 2009 14:24 uur
tijd
Aangenomen door
1O.2.e
Betreft
Inhoud gesprek
heeft in de jaren 1999 tot 2001 implantaten van
Rofil (PIP) geplaatst.•vond al snel dat deze sneller leken te
scheuren dan die van andere leveranciers. Na verloop van tijd
kreeg een zekere naam onder patienten met problemen, en
heeflook explantaties gedaan bij patienten die niet door hem
waren geimplanteerd.zag ook gevallen van siliconomen in de
oksel bij producten van Rofil. Dit zijn knobbels die ontstaan na
lekkage van siliconen. Rofil is de enige waarbijdit probleem
heeft gezien. Drie vier jaar geleden had veel explantaties van
gescheurde implantaten, maar tegenwoordig is het rustiger.
heeft een aantal keren gescheurde implantaten gezien, die als
losse brokken in de borst lagen. Het bleek ook mogelijk om
implantaten met de hand te scheuren, alsof de envellop heel sterk
-
•
0
achteruit was gegaan. kreeg het idee dat PIP te makkelijk de
krachten tijdens implantatie de schuld gaf, en niet genoeg naar de
eigen kwaliteit keek om het product te verbeteren.had ook het
idee gekregen dat het faillissement van Rofil een manier was om
dames met claims op grote afstand te zetten.
0
0
Een punt dat niets met Rofil te maken heeft,
Buiten
0
Wob-verzoek
Inspectie voor de gezondheidszorg
Blad:
Af handeling
Afspraak / advies
Te behandelen door
Kopie naar
Afgehandeld op
Bewaren
Vernietigen na
Rofi) en
1O.2.g.
8. Sep, 2009 16:04
PhHoder Aesthecs S, V,
5.
r, 6474
P. 1
Philoderm®
Ae.trwtHzs B.V.
THE
BEAUTY
PHILOSOPHY
Inspectie voor cle Volksgezondheid
1O.2.e t.a.v.
Inspecteur
1O.2.e
Postbus 90700
2509 L$ Den Haag
Breda, 7 september 2009
Inzake: RoN Medical Nederland/Philoderm Aesthetics
1O.2.e
Geachte
Naar aanleiding van uw schrijven van 9juli j.l. deel Ik u het volgen
de mede.
Philoderm Aesthetics heeft geen medische hulpmiddelen overge
nomen van de ter zIele gegane
ondernemingen Rofil Medical Nederland en Rofil Medical Interna
tional.
De mededelingen van de curator in deze zijn pertinent onjuisti
Philoderm heeft een geheel nieuwe lijn injecteerbare rimpelvullers
en mamma protheses ontwikkeld,
waarvoor op dit moment de CE certificering in gang gezet Is.
Deze hulpmiddelen worden nog niet in de Europese Gemeenschap
afgezet. Verkoop vindt wel plaats
in een groot aantal niet EU-landen, waarde registratie wel
reeds tot stand gekomen is
Ons bedrijf levert wel een ruim assortiment cosmetische produk
ten, ook binnen de EU.
Mededelingen van derden, als zou Philoderm Aesthetics bijvoo
rbeeld op dit moment borstprotheses
afzetten binnen de EU zijn pertinent onjuist!
De nazorg van door Rofil geleverde medische hulpmiddelen
: de curator zal wat dit betreft zijn
verantwoordelijkheid moeten nemen Hij was het uiteindelijk ook,
die in het hoger beroep, dat Rofil
instelde tegen het door een oud-medewerker aangevraagde
faillissement, voor een bedrag van 5.500
(1) euro, een negatief advies gaf aan het Gerechtshof.
Philoderm Aesthetics kan juridisch niet handelen namens
Rofil.
Overigens verklaart Philoderm zich bereid een constructieve
rol
in de nazorg te spelen.
1-feusing 16 4817 ZB Breda o The Netherlands T ÷31(0)
76 5781311 oF +31 (0)76 5781312
E info@phlodermaesthezicscom www.phuoderrnaesthetics.c
om KvK Breda 20062037 o\IAT NL 801 1.40894.a01
Philoderm Aesthetics BV is ISO 9001 and 13485 cerified
8. Sep, 29 16:4
PHloderr Aesthetcs 8, V,
Nr. 6474
P. 2
Phlloderm®
AsthtlcE.
THE
BEAUTY
PHlLO5OPH’’
Intussen heb ik mogen vernemen, dat er tegen Phfloclerm Aesthetics
en ondergetekende door
derden, meer in het bijzonder door oud-werknemers, concurrerend
e bedrijven en aan de kant
geschoven natified bodies, een ware hetze bij cle Inspectie door de
Volksgezondheid in gang is gezet,
kennelijk met de bedoeling om Philoderm Aesthetlcs te gronde
te richten,
Zelfs inbraken bij het bedrijf en de vernieling van essentiele docum
enten worden daarbij 1
ingezet Om
nog maar niet te spreken van ernstlge bedreigingen aan het adres
van ondergetekende.
lnclianenverhalen over het in de markt zetten van geëxpireerde produk
ten e.d. zijn te waanzinnig
voor woorden! Ons bedrijf is nog onlangs geïnspecteerd door de
Keuringsdienst van Waren inzake de
handel in cosmetische produkten.
Jarenlang is Rofil gecertificeerci door notified bodies als KEMA TUV,
,
DQS, LGA e.a. Er is altijd sprake
geweest van een fatsoenlijk handelend bedrijf. Als directeur van Philod
erm Aesthetlcs heb ik ook de
Intentie een dergelijk beleid in te voeren bij het nieuwe bedrijf.
Helaas lijkt dit niet rriogelljkl
Een en ander heeft ons doen besluiten om Nederland als produktieen clistributieland te verlaten.
Ook de certificering van de nieuw ontwikkelde produkten zal elders
In de EU plaatsvinden. Philoderm
Aesthetics zal daar niet langer verantwoordelijk voor zijn.
Wij menen, dat ons het werken onmogelijk is en wordt gemaakt in
Nederland.
Met vri fflfiiîi
1O.2.e
i.’--
ur
BV.
33.
aRd
1O.2.e
‘‘-:‘
‘:-
-
1O.2.e
Inspectie Gezondheidszorg
2509 LS DEN HAAG
Y
—
I
-.-
..-...
-
:
DATUM
Bi.tpr 1
$817HXBREDA
POSr-bus 4714
4803 ES BREDA
-
—
—_
LO.2.e
Wakdjil
R-MAIL
PoSr-ADREA
ONDERWERP
-+31 88 253
+3188 253
rCOT
Postbus 90700
—,-.
_L.
Neoerraiid
TBÎBIY- wkd.ni
6 mei 2010
failHssement Rofil Medical Nederland BV
UW KENMERK
ONS KENMERK
1O.2.e
.1.
Geachte
Naar aanleiding van uw telefonisch ver-zoek treft u hierbij aan afschriften van de debiteurenfacturen van
gefailleerde over 2008 en 2009.
Voormelde facturen doe ik u toekomen omdat u te kennen heeft gegeven dat de Inspectie Gezond
heidszorg hieruit hoopt te kunnen afleiden welke klinieken cq. medische instellingen van gefailleerde de
borstprotheses van PIP hebben afgenomen. Deze borstprotheses blijken bij de dragers ervan namelijk
gezondh
te kunnen leveren door (met name) rupturen.
1O.2.e
AKD
BjIaen
AKD s wn hand&snaam van ARD Prinsen Vn Wjmn nv, Drdenrekersno: i7.8ûOL677. Voor &aarnenp
beperkne van de eansprakeNjkhed se achterzijde.
voorwaarden en
AKDa2145S21vi
46.
Inspectie vcxr de Gezcndheidszorg
C
)‘ntoor1ftrecht
DOP
Nr
Ingekomen
©üLMEDRO
08 JUL 2010
Medizinische Produkte
—-
R&Otie
Roll Medro GmbH
-
Waaqenstrasse 32
•
ft
0-102 9 Düssel
Melding
rI ci.
Inspectie voor de Gezondheidszorg
Postbus 2680
3500 GR Utrecht
ROFIL MEDRO GmbH
Waagenstrasse 32
0-40229 Dü”
Telefon (02 11)
Telefax(0211)
E-maH: [email protected]
Internet: htto :/,fwww.rofimed rode
-
Nederland
06.07.20 10
P.LP. BREAST-IMPLANTS
Poly Implant Prothèse
Registration No.:
CE-Certificate 13.12.2007
Dear Sirs
From September 2009 until 30.03.2010 we were distributor for above implants.
Do you have some information in the meantime what kind of implants or which charges were
concemed using the not certified gel.
Looking forward to your soonest reply.
Managing Director
HRB Düsseldorf 29083
Geschflsführern:
Irigeborg Bron
Bankverbindungen;
Stadtsparkasse Düsseldorf
4onlo-Nr. 67011 890, (BLZ 300 501 10)
BAN-Nr. DE43 300501100067011890
Dresdner Bank Düsseldorf
Konto-Nr. 0421520500 (BLZ 300 800 00)
IBAN-Nr. DE 16300800000421 520500
BIC DUSS DE DD XX
BIG DRES DE EF 3CC
TUVRheinland
APPROVAL
EC Directive 93/42IEEC Annex II, Article 3
Full Quality Assurance System
Medical Devices
Manufacturer:
Scope:
Registration No.:
HD 60020025 0001
Report No.:
28407066 001
Poly Implant Prothèses
337 avenue de Bruxelles
83507 La Seyne s/Mer Cedex
France
Design and development, manufacturing and distribution of
breast implante
Products: see attachnient
Replaces Approval, Registration No.: HIJ 60007473 0001
Date of Expiry:
07.12.2012
The Notifled Body hereby authorizes the quallty
company mentioned above. The requlrements of
This approval Is subJect to perlodic surveillance,
EC Directive, and can be used by the company
management system established and applied by the
Annex II, Artiole 3 of the directive have been met.
defined by Annex Ii, Article B of the aforementioned
with the manufacturer’s declaration of conformity.
7çs
Cologne,
‘—
13.12.2007
..NNotIfIed Body
tüvFh&nId
—
TUV Rheinland Product Safety GmbH
-
1O.2.e
Am
-
rauen Stem
-
D-51 105 KöIn
Accredited by Zentraistelle der Lnder für Sicherheitstechnik (ZLS) and
Zentralstelle der I.nder fOr Oesundheîtsschutz bei Arzneimittein und Medizinprodukten (ZLG).
Notifled under No.
CE
0197
to the EC Commission.
The CE marking may be used if all relevant and effective EC Directives are complied with.
((
W02l 20(0
TUVRheinland
TÜV Rheinland
Product Safety GmbH
Doc.
1/1,
Rev.
0
Am Grauen Stem, D-51105 KöIn
Attachment to
Registration No.:
Report No.:
HD 60020025 0001
28407066 001
Manufacturer:
PoJy Implant Prothèses
337 avenue de Bruxelles
83507 La Seyne s/Mer Cedex
France
Scope:
Produets:
Pre-fi].led breast implant6:
Smooth saline pre-filled breast implants: IMPHY-LS
Micro-Textured saline pre-filled breast implants: IMPHY-MX
Smooth high cohesivity gel pre-filled breast implants:
IMGHC-LS
Micro-Textured high cohesivity gel pre-filled breast
implants: IMGHC-MX
Textured high cohesivity gel pre-filled breast implants:
IMGHC-TX
-
-
-
-
-
Accessories:
Smooth infiatable Sizer: GABGF-LS
Smc,oth high cohesivity gel pre-filled Sizer: GABGL-LS
Smooth Hernicylindrical Expanders: EXPHC-LS
Smooth Hemispheral Expanders: EXPHS-LS
Smooth Reconstruction Expanders: EXPRE-LS
-
-
-
-
-
Cologne, 13.12.2007
W2O ‘cJ
49.
Van:
Aan:
Onderwerp:
Datum:
Bijlagen:
Dienstoostbus IGZ Loket Utrecht
“inforoiImc1rode”
Our reference
Managing Director
vrijdag 16 juli 2010 16:25:00
imaae0p2.ioci
-jdl
—
Your reference M-IMPLANTS, letter froii
1O.2.e
Dear
We hereby acknowledge receipt of the letter, dated 06-07-2010, concerning your
question about the M-IMPLANTS.
Your letter, registered under reference number
inspector responsible,
Yours faithfully,
Head of the IGZ Information Office
Health Care Inspectorate
IGZ Information Office
P.O. Box 2680 1 3500 BR 1 Utrecht 1 The Netherlands
T +31 (0)8________
F +31 (0)88
Email loketroznl
Internet wwwiQz.nl
will be forwarded to the
1O.2.e
66.
Health Care Inspectorate
Ministry ofHealth, Welfare and Sport
>
Postal address P0 Box 90460 2509 LL The Hague The Netherlands
TÜV Rheinland Product Safety GmbH
Am Grauen Stem
D—51105 Köln
DEUTSCHLAND
Pharniaceutical Affairs And
Medlcal Technology
WiIh. van Pruisenweg 52
The HagUc
2509 LL The Hague
The Netherlands
T +3170
F +31 70
www.lgz.ni
Xnformatlon with
1O.2.e
The Hague, September 16, 2010
Subject
ofil-M-1mplants 1O.2.e
iqz.ni
T +31 70
Dear Madam/Sir,
Enciosure(s)
On 30 March 2010 the French corn petent authority for medical devices, Afssaps,
informed the Dutch Health Care Inspectorate about a recail for breast implants,
manufactured by Poly Implants Prothesis (PIP). Since then we learned that the
Dutch comparlies Rofil Medical International N.V. and Rofil Medical Nederland B.V.
(Rofil) have been the manufacturer of breast implants of the brand M-Implants.
These implants were produced by PIP and they were identical to the implants that
have been recalled. Both Rofil companies have gone into bankruptcy, in August
2008 and February 2009 respectively. This makes t impossible for us to obtain
relevant documents.
Your reference
Your letter
However, we also found out that TÜV Rheinland has probably been the notified
body for these devices. 1f this is the case, 1 would like you to send me the
following information:
1. All documents concerning the certification of devices manufactured by Rofil
and PIP;
2. All documents concerning vigilance for products manufactured by Rofil and
PIP;
3. All certificates related to any device manufactured by Rofil and PIP;
4. Any other information you may find relevant for us with regard to this recail.
Would you be so kind to send this information to:
RIVM
Section Medical Technology (PBSO)
P0 Box 1
3720 BA Bilthoven
THE NETHERLANDS
1 would be pleased to receive your information before 4 October 2010.
1O.2.e
Page 1 of 1
69.
pagina 1 van 3
1O.2.e
Van:
1O.2.e
IGZ
Verzonden: woensdag 22 september 2010 14:32
Aan:
_Dienstpostbus IGZ Zuidwest
Onderwerp: FW: Antwort: RE: Rofil
Urgentie:
Hoog
Bij Ja ge n
+
PIP
RMN Auditreport 2008.pdf; RMN Incident Status Overview,pdf; RMN Cancellation.pdf; RMN Quality Manual
Excerpt 1_3.pdf; RMN Quality Manual Excerpt 2_3.pdf; RMN Quality Manual Excerpt 33.pdf; RMN Annex
Jl3.pdf: RMN Annex I.4pdf
graag aan melding
Recail PIP hangen. 1O.2.e
1O.2.e
Graag ook meteen kopie maken voor mij
1O.2.e
Van:
Verzi
Aanij
[
‘de.tuvcom] 1O.2.e
2010 14:12
[mailtol
-
T
cc:r
)zlg.nrw.c.
Onderwerp: Antwort: RE: Rofil +
Dear
r’
‘7
1O.2.e
1O.2.e
as agreed yesterday, please find attached the following information:
Auditreport with sorne information on vigilance handling procedure:
Certificats of RMN and cancellation letters:
Quality Manual of Rofil/RMI/RMN inciuding vigilance procedures:
To schedule a meeting in Cologne this week, wifl be quite difficult, since t will be in Nuremberg tomorrow.
Just to let you know, the former responsible auditor for RMN will be in holidays until October 12, 2010. In my opinion
it makes
more sense, when he participates, but the documents are stil! available,
Maybe we should talk again on the phone to fix a date.
Wth best regards
1O.2.e
General Manager MedicailBusiness Division Products
Branchenleiterin Medical/Geschëftsbereich Produkte
ione +49
Cellular +49 (C,
22-09-2010
1O.2.e
pagina 2 an 3
Fax ÷49 (0
:
.
TÜV Rheinland LGA Products GmbH
TUV Rheinland Group
Am Grauen Stem
51105 Köln-PolI
www.tuv.com/safety
Geschft
iof Management
1
Nürnberg HRB 26013
Bel Fragen erreichen Sie unser Team vom Kunden-Service-Center unter 0800 5 888 770 oder [email protected]
In case of questions you will reach our team from customer service center +49 0)911 655 5225 [email protected]
Bitte denken Sie sri die Umwe1, bevor Se diese Nacnr:cht drucken.
Before ou print, piesse theik about the env:ronment
9Z
1>
10 2 e
An
Kopie
Thema RE: Rofil
22.09.2010 08:26
Dear
de tuv corn>
PIP
10.2.e
Thank you for your quick response and the cooperation you offer. We are trying to arrange a meeting in Köln
this week. 1 will keep you informed about that.
Best Regards,
10.2.e
Inspector
Dutch Healthcare Inspectorate
Ministry of Health, Weifare and Sports
Wilhelmina van Pruisenweg 52 1 2595 AN 1 Den Haag
P0. Box 90700 1 2509 LS 1 Den Haag
T +31 70
1
1
Room 5-004
10.2.e
p!Lww.ignI
e.tuv.comj
10.2.e
uzlg.nrw.de
Dear
10.2.e
10.2.e
it was nice talking to you today.
As agreed, we will send you relevant vigilance information of Rofil by tomorrow. And then we will decide how to continue.
22-09-2010
pagina 3 van 3
Have a nice evening
O.2.e
(general Mnager Medical/Business Division Products
Branchenlejterin Medical/Geschftsbereich Produkte
TÜV Rheinland LGA Products GmbH
TUV Rheinland Group
Am Grauen Stem
51105 Köln-Poll
wwwtuv.com/safety
of Management
[
1O.2.e
Nürnberg HRB 26013
Bel Fragen erreichen Sie unser Team vom Kunden-Service-Center unter 0800 5 888 770 oder
n case of questions you will reach our team from customer service center +49 0)911 655 5225 [email protected]
or [email protected]
Bitte denken Sie en die Umvieft, hevor Se diese Uschricht drucken,
Before you print, piesse thirk about the covironment,
Dit bericht an informatie bevatten de niet voor ii is bestemd. udien u niet de seadresseerde bent
of dit bericht abusievelijk aan u is toesezonden. wordt u verzocht dat
aan de afzender te melden en het bericht te verwijderen. De Staat aanvaardt geen aansprakelijkheid
voor schade, van welke aard ook, die verband houdt niet risico’s
verbonden aan het elektronisch verzenden van berichten.
This message may contain information that is not intended for you. t you are not the addressee
or ii this massage was sent to you by mistake, you ere requested to inform
the sendar and delete the massage. The State accepta no Iiabfty for damage of any kind resulting from
the rsks inherent in the elactronic transniission of messages.
22-09-2010
70.3
TÜVRheinIand®
Business Stream Products
QQCertification Body
TÜV Rheinland Product Safety GmbH
Genau. Richtig.
D-51 101 Cologne
1O.2.e
Rofil Medical Nederland B.V.
(Philodem Aesthetics B.V.)
Heusing 16
4817 ZB Breda
The Nederlands
303-vi-ger
Fax
+492 21.8 06-1601
Mail trps-certification
@de.tuv.com
customer service center
for products
phone +49 221 806 1400
Cologne, 16.06.2009
HD 60022415 0001, SX 60022416 0001, SY 60022417 0001
Dear
1O.2.e
We had received your information, that the certified company
Rofil Medical Nederland B.V. does no longer exist.
Therefore the approval HD 60022415 0001, and the certificates SX 60022416 0001,
SY 60022417 0001 are no longer valid.
Please consider the following effects:
E
E
c
t
t
It is not allowed any longer to label any newly produced device with the CE mark,
combined with the Notified Body number (0197) of TÜV Rheinland Product Safety
GmbH (TRPS).
It is not allowed any longer to place devices with the CE mark, combined with the
Notified Body number (0197) of TÜV Rheinland Product Safety GmbH (TRPS), on
the European market.
t,
t
t
Additionally it is no longer allowed to make reference to the above mentioned
certificates, e.g. for marketing purposes or in contractual agreements.
0
t
>
In case of any questions do not hesitate to contact us.
TOV Rheinlard
Product Safety GmbH
0,
z
0)
w
Sincerely,
Am Grauen Stem
0-51105 Köln
Certification Body
Tel.
Fax
Mail
Web
t
0,
1O.2.e
+491803112112
+491803000169
[email protected]
www.tuv.comisafety
Board of Management
Dipl.-Ing.
t
>
D
Dipl.-Wirtsch.-lng.
0
>
D
1-
S
S
cologne HRB 25960
VAT Registration:DE8I 1835490
DECLARATION
To:
TÜV Rheinland Product Safety GmbH
Medical Device Services
Am Grauen Stem
51105 Cologne
Germany
We hereby declare that:
1) Certificates: HD 60022415 (11.3, breast implant approval) and SY 600022417 (EN
ISO 9001:2000) and ID 60017891 (breast implant, 11.4) which expire in March
2009 shali not be renewed.
2) No more orders to production under the above
—
listed certificates will be issued.
3) It is the interitfon of Philoderm Aesthetics BV to distribute the M
product currently in stock.
—
lmplants
‘
Name of signatory:
Title: Presfr’
Signature:
Stanjpof
1O.2.e
..
.
Pcierm Philoderm Aesthetics B.V.
Heusing 16
48I7ZB Breda
Phone nr. +31(0)76.5781311
Fax nr. +31(0)76.5781312
www.phIlodemiaeslheDcs.com
[email protected]
KvK 20062037
4.
14.
Jaii,
2Ü9 15:13
r. 5462
Roil iedca1 ned, bv
P. 1
Rofil Modical Noderand BN.
Heusing l6oo 4BI7ZB Brcda’Thc Ncthcrlands
T+31 (0)76 5315670 ‘F+31 (0)76 5315660
£ infû5rofi1.eonoo 1 www.yofil.com
-
03.07.03
t%S.j
Message by Telefax
Company
For the attention of
ax number
Number of pages
Subject
Date
Reference
Dear
TÜV Rheinland Product Safaty GmbH
1O.2.e
;
+49—221—lJ6 1601
1
Change of name
15 January 2008
09733 TLIt1
‘-
1O.2.e
Hereby 1 would like to inform you that the name of the company Rofil Medical
Nederland BV has been changed into “Philoderm Aesthetics BV”.
. ff..
CL12
Please see attached the copy of the registration by the Chamber of Commerce Osi .O.O3
The company remains at the same address and keeps the same quality system.
Therefore we apply for new certificates with the chan9ed company name. Also the
one for Canada.
As you can understand, this is urgent for us n order to proceed with the re labeling
of the products. Could you please advice as to when we can expect the new
certificates?
—
Regarding the dates you suggested for the coming up audit 1 would like to confirm
that we agree with 21 & 22 of April (CM DR).
Best regards,
:
1O.2.e
RA Manager
1f this transmission has not been correctly received, please inform us immediately.
Tel.; +31 (0)76 531 56 10 Fax; +31 (0)76 531 56 60
k2(
Van:
IGZ
Aan:
Onderwerp:
Datum:
Bijlagen:
160
10.2.e
Io(IflrmapsthptIcscom
Conceptverslagen
dinsdag 5 oktober 2010 16:01:00
2OlO268El44 M23516 Concept bezoekvelsiaci 23-09-2010pdt
2010-268852 M23516 Concept bezoekverslee 23-09-2010.pdf
Geachte
,
10.2.e
Hierbij ontvangt u de conceptverslagen van ons inspectiebezoek van 23 september
2010 per mail. Deze verslagen zijn u ook per normale post verstuurd. Ik wil u
verzoeken er zorg voor te dragen dat
deze verslagen ook ontvangt.
10.2.e
Hoogachtend,
10.2.e
Inspecteur
Inspectie van de Gezondheidszorg
Ministerie van Volksgezondheid, Welzijn en Sport
Wilhelmina van Pruisenweg 52 1 2595 AN 1 Den Haag
Postbus 90700 1 2509 L5 1 Den Haag
T+3170304
F +31 70 304
M +31 (
1
1 S’IVI
02
1
Kamer 5-004
102e
znl
fl1
Voor een gerechtvaardigd vertrouwen in verantwoorde zorg
168
1O.2.e
Van:
ÎE,w.rp:
Datum:
Bijlagnn:
1 G Z+ RIVIVI
Ron documents part 1
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10.2.e
Pleane bed uttuched the requented documents. We hane uparated documents iets 2 emuils.
(t hope you haue been able prepere your email account!).
eest reqerds,
Flediuinprudekte/Medicul Devicen
10.2. e
de.tuu.com
Phone+49
Pae +49
10.2.e
TÜV Rhreinlarsd LGA Pmducts Gmbll
TUV Rheieland Gmup
Are Grauen Stem 29
D-91109 Kdle-PoII
www.tw.com/safaty
Geuchbbehihrung/Board of Managemeet
Nürnberg HRB 26013
Bel Fragen erreichen 91e enner Team som Keeden-Service-Ceeter unter 0990 S 999 770 oder [email protected]
In cate of queutioen you will reach our team from customer service ceeter +49 (0)911 695 5225 or [email protected]
Bitte denken 91e en die Umwelt benor Sie d:eue Nachricht drucken.
Before you print, pleane think about the eneironmeet.
Weitergeleitet von
/PS/D6/TU6V am 09.19.20t0 17:26
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09.10.2010
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[email protected]>
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Kopie
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Zertiflkute
(See attached 91e: Document.pdO
Weitergeleitet non
PS/D6/TUEV am 09.00.2010 17:25
09. 00.20 10
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c@detuvcomv
As
10.2.e
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Print
order
(See attached tOe: Document.pd)
Weitergeleitet von
/PS/DE/TUEV am 05.10.2010 17:25
-
-
1 O.2.e
TUV Rheiriland LGA Productu GmbH
@de.tuv.corn>
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Revisiorisotand
(See attached file: Document.pdfl
Weitergeleitet von
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Product
Deocription
(See attached file: Document.pdt)
Weitergeleitet von
/PS/DE/TUEV am 05.10.2010 17:25
“TUV RIjeinland LGA Products GmbH
@de.tuv.com>
1O.2.e
1O.2.e
05.10.2010
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Application
(Sea attached file: Document.pdfl
Weitergeleitet von
IPSIDEITUEV am 05.10.2010 17:25
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TUV Rheinland LGA Products GmbH”
@de.tuv.corn>
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15:09
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1O.2.e
@de.tuv.com>
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Application
History
(See attache file: Document.pd
Weitergeleitet von
IPS/DE/TUEV am 05.10.2010 17:25
1O.2.e
TUV Rheinland LGA Products GmbH
@de.tuv.com>
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report Design Dossier
codate
(Sea attached file: Document.pdf)
Weitergeleitet von
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TUV Rheinland LGA Products GmbH
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risk
management
(See attached file: Document.pdfl
Weitergeleitet von
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—
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DSM
CONTRACT
(See attache file: Document.p&)
Weitergeleitet von
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DD Report
26. 5.2004
(Sea attache file: Document.pdt)
-
Zweitschrift (Copy)
-
168.1
EC Design Examination Certificate
EC Directive 93142/EEC Annex II, Article 4
Medical Devices
Registration No.:
ID 60008171 0001
Report No.:
21112263 002
Manufacturer:
Manufacturing Facility:
Rofil Medical
International N.V.
Heusing 16
4817 ZB Breda
Netherlands
Rofil Medical
International N.V.
Heusing 16
4817 ZB Breda
Netherlands
Product:
Medical Device
Mammary lmplants
Identification:
Smooth, micro—textured and textured high cohesivity
gel pre-filled breast implants
Products: see attachment
Inh.
=
452431
/
Deb.
=
452431
/
Fert.
=
452431
The EC design examination certificate refers to the above rnentioned product. It certifies that
the design documentation of the product complies with Annex II, Article 4 of the directive.
The manufacturer is subject to EC surveillance in accordance with Annex II, Article 5 of
the directive. The manufacturer is entitled to use this certificate with the manufacturer’s
declaration of conformity.
Date of Expiry:
Notified Body
14.03.2009
1O.2.e
Cologne, 22.06.2004
TÜV Rheinland Product Safety GmbH
-
Am Grauen Stem
D-51 105 KöIn
-
Accredited by Zentralstelle der Lander für Sicherheitstechnik (ZLS) and
Zentralstelle der Lânder fOr Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG).
Notified under No.
C€
:-‘—--“
01 97
to the EC Commission.
The CE marking may be used 1f all relevant and effective EC Directives are complied with.
1
.
.
.
.
.
..
.
...
.
.
,...-.
t
CE
-
Zweitschrift / copy
TÜV
-
Doc. 1/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, D-51105 KöIn
Attachment to
Regîstration No.:
Report No.:
ID 60008171 0001
21112263 002
Man ufacturer
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda
Nethe rian ds
Scope:
Mammary Implants
IMGHC-LS-S : Smooth surface standard profile high cohesivity gel pre-filled breast implant
CODE
SURFACE
PROFILE
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOQTH
SMOOTH
SMQOTI-f
SMOOTH
SMOOTH
SMOOTH
SMDOTH
SMOOTH
SMOOTH
SMOOTH
SMO0TH
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
-
VOLUME
DIAMETER
PROJECTION
(cc)
(mm)
(mm)
85
105
125
145
165
185
205
225
245
265
285
305
325
345
365
415
455
505
555
605
655
705
87
92
97
102
106
108
110
114
117
124
126
128
130
132
136
141
145
150
156
160
166
172
18
20
21
23
26
27
28
29
30
31
32
33
34
35
34
35
36
37
38
39
40
41
Cologne, 2004-06-21
1O7.St
i
4
-f
-
•it
f
-
Zweitschrift / copy
-
TÜV
Doc. 2/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, D-51105 KöIn
Attachment to
Registration No.:
Report No.:
ID 60008171 0001
21112263 002
Man ufactu rer
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda
Netherlands
Scope:
Mammary Implants
IMGHC-LS-H : Smooth surface High profile High cohesivfty gel pre-filled breast implants
CODE
SURFACE
PROFILE
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HiGH
HIGH
HIGH
HIGH
HIGH
HIGH
VOLUME
DIAMETER
PROJECTION
(cc)
(mm)
(mm)
90
130
150
170
190
210
230
250
270
290
310
330
350
390
430
470
510
570
620
680
80
84
90
94
98
102
105
109
112
115
118
121
126
128
135
142
146
151
157
160
29
32
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
Cologne, 2004-06-21
1WtO7
-
Zweitschrift / copy
-
TÜV
Doc. 3/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, D-51105 KöIn
Attachment to
Registration No.:
Report No.:
ID 60008171 0001
21112263 002
Manufacturer
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda
Netherlands
Scope:
Mammary Implants
IMGHC-LS-UH : Smooth surface UItra-Hgh profile High cohe&vity gel pre-fifled breast implants
CODE
SURFACE
PROFILE
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
Cologne, 2004-06-21
VOLUME
DIAMETER
PROJECTION
(cc)
245
265
295
335
365
405
425
495
(mm)
101
104
107
112
116
120
123
128
(mm)
50
51
53
54
56
58
60
62
1O.2.e
1WO 7.95k
—
t
‘4
14
-
-
-
-
-
Zweitschrift / copy
--:
-
tz
TÜV
Doc. 4/12, Rev. 0
TÜV Rhein land
Product Safety GmbH
Am Grauen Stem, 0-51105 Köln
Attachmentto
Registration No.:
Report No.:
ID 60008171 0001
21112263 002
Man ufactu rer
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda
Netherlands
Scope:
Mammary lmplants
MGHC-MX-S: Micro-Textured surface Standard profile High cohesMty ge! pre-fihled breast implants
CODE
SURFACE
PROFILE
VOLUME
(cc)
DIAMETER
(mm)
PROJECTION
(mm)
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
MGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MCR0TEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
85
105
125
145
165
185
205
225
245
265
285
305
325
345
365
415
455
505
555
605
655
705
87
92
97
102
106
108
110
114
117
124
126
128
130
132
136
141
145
150
156
160
166
172
18
20
21
23
26
27
28
29
30
31
32
33
34
35
34
35
36
37
38
39
40
41
Cologne, 2004-06-21
-—--—..
---—
-
—
1
.-.---..-
1a7s
-
Zweitschrft / COPY
-
TÜV
Doc. 5/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, 0-51105 KöIn
Attachment to
Registration No.:
Report No.:
ID 60008171 0001
21112263 002
Manufacturer
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda
Netherlands
Scope:
Mammary lmplants
IMGHC-MX-H : Micro-Textured surface High profile High cohesivity gel pre-fihled breast implants
CODE
SURFACE
PROFILE
VOLUME (cc)
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
90
130
150
170
190
210
230
250
270
290
310
330
350
390
430
470
510
570
620
680
DIAMETER
PROJECTION
(mm)
(mm)
80
84
90
94
98
102
105
109
112
115
118
121
126
128
135
142
146
151
157
160
29
32
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
Cologne, 2004-06-21
1Q,ttJ 7.
•;1:-•
-
Zweitschrift / copy
-
TÜV
Doc. 6/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, 0-51105 KöIn
Attachment to
Registration No.:
Report No.:
ID 60008171 0001
21112263 002
Manufacturer
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda
Netherlands
Scope:
Mammary Implants
IMGHC-MX-UH: Micro-Textured surface Ultra-High profile High cohesivity gel pre-filled breast implants
CODE
SURFACE
PROFILE
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
VOLUME
DIAMETER
PROJECTION
(cc)
(mm)
(mm)
245
265
295
335
365
405
425
495
101
104
107
112
116
120
123
128
50
51
53
54
56
58
60
62
Cologne, 2004-06-21
10/020 7.95
9
-
Zweitschrift / copy
-
TÜV
Doc. 7/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, 0-51105 KöIn
Attachment to
Registration No.:
Report No.:
10 60008171 0001
21112263 002
Man ufacturer
Rofil Medical International NV.
Heusing 16
4817 ZB Breda
Netherlands
Scope:
Mammary Implants
MGHC-TX-S : Textured surface Standard profile High cohesivity gel pre-filled breast implants
CODE
SURFACE
PROFILE
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
—
VOLUME
(cc)
85
105
125
145
165
185
205
225
245
265
285
305
325
345
365
415
455
505
555
605
655
705
DIAMETER
(mm)
87
92
97
102
106
108
110
114
117
124
126
128
130
132
136
141
145
150
156
160
166
172
PROJECTION
(mm)
18
20
21
23
26
27
28
29
30
31
32
33
34
35
34
35
36
37
38
39
40
41
Cologne, 2004-06-21
-
F
—
-
—
-.
-
Zweitschrift / COPY
-
TÜV
Doc. 8/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, D-51105 KöIn
Attachment to
Registration No.:
Report No.:
ID 60008171 0001
21112263 002
Manufacturer
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda
Netherlands
Scope:
Mammary Implants
IMGHC-TX-H : Textured surface High profile High cohesivity gel pre-fihled breast implants
CODE
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
SURFACE
PROFILE
VOLUME (cc)
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
90
130
150
170
190
210
230
250
270
290
310
330
350
390
430
470
510
570
620
680
Cologne, 2004-06-21
:4:;
DIAMETER
(mm)
80
84
90
94
98
102
105
109
112
115
118
121
126
128
135
142
146
151
157
160
PROJECTION
(mm)
29
32
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
-
.
-
Zweitschrift / copy
-
TÜV
Doc. 9/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, D-51105 KöIn
Attachment to
Registration No.:
Report No.:
ID 60008171 0001
21112263 002
Manufacturer
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda
Netherlands
Scope:
Mammary Implants
IMGHC-TX-UH Textured surface ultra-High profile High cohesivity gel pre-filled breast implants
CODE
SURFACE
PROFILE
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
Cologne, 2004-06-21
VOLUME
DIAMETER
PROJECTION
(cc)
(mm)
(mm)
245
265
295
335
365
405
425
495
101
104
107
112
116
120
123
128
50
51
53
54
56
58
60
62
--
-
i
-.
Zweitschrift / copy
-
TÜV
Doc. 10/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, D-51105 KöIn
Attachment to
Registration No.:
ReportNo.:
ID 60008171 0001
21112263 002
Man ufactu rer
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda
Netherlands
Scope:
Mammary lmplants
IMGHC-TX-R: Textured surface Reconstruction proffie High cohesivity gel pre-filled breast implants
CODE
SURFACE
PROFILE
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
RECONSTRUCTION
RECONSTRUCTION
RECONSTRUCTION
RECONSTRUCTION
RECONSTRUCTION
RECONSTRUCTION
RECONSTRUCTION
WIDTH
HEIGHT
(cc)
(mm)
(mm)
180
220
260
330
420
500
600
111
113
120
127
132
143
154
96
98
98
111
118
124
137
1O.2.e
Cologne, 2004-06-21
t
VOLUME
r
-‘
T
i,
—
PROJECTION
MAXI (mm)
39
41
44
48
53
57
60
-
Zweitschrift / copy
-
TÜV
Doc. 11/12, Rev. 0
TÜV Rheinlancl
Product Safety GmbH
Am Grauen Stem, D-51105 KöIn
Attachment to
Registration No.:
ReportNo.:
ID 60008171 0001
21112263 002
Manufacturer
Rofil Medical International NV.
Heusing 16
4817 ZB Breda
Netherlands
Scope:
Mammary lmplants
IMGHC-TX-AL: Textured surface Asymmetrical profile High cohesivity gel pre-filled breast implants
CODE SURFACE
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHÖ
IMGHC
IMGHC
IMGHC
PROFILE
TEXTURED ASYMMETRICAL
TEXTURED ASYMMETRICAL
TEXTURED ASYMMETRICAL
TEXTURED ASYMMETRICAL
TEXTURED ASYMMETRICAL
TEXTURED ASYMMETRICAL
TEXTURED ASYMMETRICAL
TEXTURED ASYMMETRICAL
TEXTURED ASYMMETRICAL
TEXTURED ASYMMETRICAL
Cologne, 2004-06-21
VOLUME
200
230
245
260
280
300
330
370
400
450
—
Left side
WIDTH(mm) HEIGHT(mm) PROJECTION (mm)
86
89
93
98
102
107
110
115
119
124
109
114
119
125
130
135
138
143
148
153
36
39
42
44
46
48
50
52
54
56
1O.2.e
-
-
—
$
Zweitschrift / copy
-
TÜV
Dcc. 12/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, 0-51105 KöIn
Attachment to
Registration No.:
Report No.:
ID 60008171 0001
21112263 002
Manufacturer
Rofil Medical International N.V.
Heusing 16
4817ZB Breda
Netherlands
Scope:
Mammary lmplants
IMGHC-TX-AR : Textured surface Asymmetrical profile High cohesivity gel pre-fihleci breast implants
side
CODE SURFACE
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
PROFILE
ASYMMETRICAL
ASYMMETRICAL
ASYMMETRICAL
ASYMMETRICAL
ASYMMETRICAL
ASYMMETRICAL
ASYMMETRICAL
ASYMMETRICAL
ASYMMETRICAL
ASYMMETRICAL
Cologne, 2004-06-21
VOLUME
200
230
245
260
280
300
330
370
400
450
—
Right
WIDTH(mm) HEIGHT(mm) PROJECTION (mm)
109
114
119
125
130
135
138
143
148
153
1O.2.e
86
89
93
98
102
107
110
115
119
124
36
39
42
44
46
48
50
52
54
56
168.5
Application for EC conformity
assessment procedure
(product-related evaluation)
TUV
TÜV Rheinland Group
Application for EC Conformity Assessment Procedure at the Notified Body for
medical device of the TÜV Rheinland Product Safety GmbH
based on the Medical Devices Directive 93/42/EEC
Annex II, section 4
D Annex III, section 2
based on the Directive for Active Implantable Medical Devices 90/385/EEC
D Annex 2, section 4
Rofil Medical Nederland BV.
Manufacturer:
(Name and Address)
Heusing 16
4817 ZB Breda
The Netherlands
EC-Authorized
Representative:
(Name and Address)
Appilcation conformity assessment product-GB.doc
Rev. 3; 2006-01-01
page 1 of 2
Application for EC conformity
assessment procedure
(product-related evaluation)
TUV
TÜV Rheinland Group
The appllcant declares,
-
-
-
-
-
-
the design description of the product is attached to this application;
that no application has been lodged with any other notified body for the same product(s)
described in the attachment(s) “Product description-GB.doc”;
to keep the design documentation including documents provided by the TÜV Rheinland
Product Safety GmbH for a period of the life-span of the medical device, but at leest for
five years after the last product has been manufactured;
that all devices in scope must meet the essential requirements set Out in Annex 1 of the
directive 93/42/EEC resp. 90/3851EEC;
to inform the TÜV Rheinland Product Safety GmbH of any changes to the approved
design or the approved product.
to notify the competent authorities and the certification body of the TÜV Rheinland
Product Safety GmbH of the following incidents irnmediately on learning of them:
i) any malfunction or deterioration in the characteristics and/or performance of a device,
as well as any inadequacy in the instructions for use which might lead to or might have
led to the death of a patient or user or to a serious deterioration in his state of health;
ii) any technical or medical reason connected with the characteristics or performance of a
device leading for the reasons referred to in paragraph i) to systematic recali of
devices of the same type by the manufacturer.
Manufacturers which do not have a registered place of business in a Member State,
additionally declare,
-
-
-
to designate a authorized representative who is established in the Community;
to inform the TÜV Rheinland Product Safety GmbH in case of changing the authorized
representative;
that the representative must make the design documentation/technical documentation,
including the declaration of conformity, available for inspection purposes for a period of
the life-span of the medical device, but at least for five years after the last product has
been manufactured.
1O.2.e
POFIL
RofH Medical Nederland BV.
Heusing 16 ci 4817 Z13 Breda c Th
T+31 (0)76 5315673 F+31 (0)7
Place, Date
(
Co
,
—
ly oindng signature
Attachment(-s): Product Description(-s)
Application conformity assessment product-GB.doc
Rev. 3; 2006-01-01
page 2 of 2
168.6
:
Appilcation for EG conformity
assessment procedure
(product-related evaluatiori)
[
TIJV
rûv Rheinland Group
Application for EG Gonformity Assessment Procedure at the Notified Body for
medical device of the TÜV Rheînland Product Safety GmbH
based on the Medcal Devices Directive 93/42/EEG
Annex II, section 4
EJ Annex III, section 2
based on the Directive for Active Implantable Medical Devices 901385/EEG
Annex 2,section4
Manufacturer:
(Name and Address)
Rofil Medical International NV
Smederijstraat 2
the Netherlai
EC-Authorzed Representative:
(Name and Address)
Application conformity assessment product-GBdoc
/%
Rcv, 3; 2006-01-01
page lof 2
Appllcation for EC conformity
assessment procedure
(product-related evaluation)
TUV
TOv flheinland Group
The appilcant declares,
*
-
-
-
-
-
the design description of tha product is attached to this application;
that no application has been lociged with any other notified body for the same product(s)
described in the attachment(s) ‘Product description-GBdoc”;
to keep the design documentation inciuding documents provided by the TÜV Rheinland
Product Safety GmbH for a period of the life-span of the medical device, but at least for
five years after the last product has been manufactured;
that all devices in scope must meet the essential requirements set Out fl Annex l of the
directive 93!42JEEC resp. 90/385/EEC;
to inform the TÜV Rheintand Product Safety GmbH of any changes to the approved
design or the approved product.
to notify the competent authorities and the certification body of the TÜV Rheinland
Product Safety GmbH of the following incidents immediately on learning of them:
i) any malfunction or deterioration in the characteristics and/or performance of a device,
as well as any inadequacy in the instructions for use whîch might leed to or might have
led to the death of a patient or user or to a serious deterioration in his state of health;
Ii) ariy technical or medical reason connected with the characteristics or performance of a
device leading for the reasons referred to in paragraph i) to systematic recall of
devices of the same type by the manufacturer.
Manufacturers which do not have a registered place of business in a Member State,
additionally declare
-
-
-
to designate a authorized representative who is established in the Community;
to infomi the TÜV Rheinland Product Safety GmbF-1 in case of changing the authorized
representative;
that the representative must make the design documentation/technical documentation,
including the declaration of conformity, available for inspection purposes for a period of
the life-span of the medical device, but at least for five years after the tast product has
been manufactured.
1O.2.e
edg,
Place, Date
ô7-Jo.%/ö-
Attachment(-s): Product Description(-s)
Application confomiity assessmiriïduct-GB.doc
Rev. 3; 2006-01-01
page 2 of 2
Rol ii Medkal International NV.
168.8
4817 ZB Breda
Heusing 16
The Netherlands
T +31 (0)76 5315670 “ F +31 (0)76 5315660
E [email protected]
1 vww.rofil,com
Medical Devices TÜV Rheinland Product Safety
Attn:
1O.2.e
1O.2.e
Am Grauen Stem
51105 Cologne
Germany
Breda, 21/09/04
Ref.: 04.488.TLJtI
Subject: Deviation topic 19
Dear
1O.2.e
1 am attaching again a copy of the risk analysis. 1 am under the impression you did
not get my letter of 10/6 (ref. 04.451 .TLftl) which 1 also sent by fax. Because, if 1 do
understand your questions correctly, the answers are in the risk management report.
The Risk Level (R) is obtained by 0 x S as explamned in page 3/15.
Thelimit for measures is given in the table atthe end of the document. The table
reflects the company policy of risk acceptability which is explained in page 15/15. As
you know the EN-ISO 14975 doos not impose a criteria but requires the
manufacturer to set up one.
The dark area of the table (no) is the “Intolerable Region”. This means that when the
risks are plotted on the table and fail in that area, risk control measures are required.
The numbers in the table is the order number of the each risk which is the same as
on the tables.
Thus the value of the risk is not the only criteria to start risk control measures. The
position on the table is. For example, if an hazard is found in high frequency (03) and
the consequences are marginal (S2) the R=6 and control measures are required.
That is not the case when the hazard is found in 10w frequency (02) and it is critical
(S3). The R is stili 6 but doos not require risk control measures.
THE
BEAUTY
PHILOSOPHY
1 hope it is all dear now. Otherwse, please let me know.
Best regards,
Rc
1O.2.e
Regulatory Affairs Manager
THE
BEAUTY
PHTLOSOPHY
Rofil Medical International N.V.
168.10
The Netherlands
Heusing 16 “ 4817 ZB Breda
F +31 (0)76 5315660
T +31 (0)76 5315670
8 [email protected] “ 1 www.rofil.com
Medical Devices TÜV Rheinland Product Safety
IO.2.e Attn:
Am Grauen Stem
51105 Cologne
Germany
1O.2.e
Breda, 10/06/04
Ref.: 04.451 .TL/tl
Subject: Report No.: 21112263_OOl
Dear
1fl do understand correctly, the points 1 need to answer before June 21 are two:
1. Point 19: Apparently you did not receive all the pages of the Risk Analysis
because we have explained all the risks in it. Also the answer to the risk
control is to be found in the Risk Management Report under point 4.1 and the
Risk table. 1 did realize that the background in the table was not printed and
that is essential for the understanding of the table. 1 am sending you again the
whole report by fax and postage.
2. Point 22: Two months ago 1 sent the OEM contract to PIP to be signed but 1
did not receive it back yet. 1 sent again an urgent fax demanding the signed
contract.
Points 6 is related with the Saline-filled implants and 1 cannot yet answer it.
1 understood from your writing that our certificates have been already released for
signing and they will be signed before the above-mentioned points have been solved.
Do 1 understand it correctly? We did not get them yet.
10.2.e
Regulatory Affairs Manager
THE
BEAUTY
PHILOSOPHY
Design Dossier
Deviation Report
t
4
TI]V Rhe)nland Product Safety GmbH
TÜV
Untemehmensgruppe
Tt)V RkielnlandiBeilln-Brandenburg
Report No.: 21112263_OOl
Product name:
M- lmplants
Type(s)/Model(s):
See product list in the PDF
Product group:
Mammary lmplants
Legal manufacturer:
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda the Netherlands
yes
OEM-Product:
no
Manufacturing
facility:
Poly Implants Protheses
337, Avenue de Bruxelles
83514 La Seyne SIM Cedex
Sterilization facility:
Information available in the file of:
Poly lmplants Protheses
337, Avenue de Bruxelles
83514 La Seyne SIM Cedex
Design Dossier file:
M-lmplants
Date:
9.04.2004
9.04.2004 (individual revision of documents status printed on each
Revision:
document)
DepartmentlGroup:
Regulatory Affairs
Author:
1O.2.e
Date
Design Dossier checklist-GB.doc
Name Reviewer 1
Rev.2; 2002-08-05
Signature Reviewer 1
page 1 of 5
Design Dossier
Deviation Report
TüVRhoinland Product Safety GmbH
TÜV
Untemehmensgruppe
10v Rh&nlandlBerlln-Brandenburg
Report No.: 21112263_OOl
Date
Date
Date
Date
of TUV Review:
of Rofil Response:
of TUV 2. Review:
of Rofil Response:
Date of TUV 3. Review:
16.
23.
05.
12.
24.
26.
April 2004
April 2004 (received at TUV 29. April 2004)
May 2004
May 2004 via email (info that draft certificate is o.k.!!)
May 2004 (responses to TUV 2. Review)
May 2004
Please find in the following our preliminary numbered findings to the provided design dossier
documents:
Responses to each deviation can be inciuded into this document. Required documents shali be
provided.
Not numbered findings are remarks er hints for improvement or clarification.
The marked deviations “t” in the 2. TUV Review are accepted for certification but
revised and missing documents need to be provided until 21. June 2004.
Time schedule need to be kept.
General
3. A concordance matrix inciuding the certified PIP devices (naming see certificate) and
naming/renaming of the private label manufacturer RMI should be provided.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: open,
In our understanding Rofil uses identical codes as PIP for their products. Please send in
corrected PDF.
Rofil response: see Rofil response dated 12. May and 24. May
TUV 3. review: closed,
yes, the response is accepted.
5. A design dossier (DD) name and/or identification number is missing. Additionally for traceability
a revision number of the DD should be inciuded.
Documents shali be revision controlled.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: open,
referenced revision file with revision status of all documents shail be provided.
Please provide “date of production” (version number) of the DD.
Rofil response: see Rofil response dated 12. May and 24. May
TUV 3. review: closed, but could be improved
Design Dossier checklist-GB.doc
Rev.2; 2002-08-05
page 2 of 5
Design Dossier
Deviation Report
TCJV Rheinland Product Safety GmbH
TÜV
Untemehmensgruppe
.
T1JV RhInIndIBedin8randenburg
Report No.: 21112263_OOl
Product Description Form (PDF)
6. Saline implants from PIP are not certifled yet and therefore not covered by the MDD
931421EEC, Annex 11.4 certificate. The ‘Product Descnption Form” (PDF) need to be revised
accordingly (saline implants should be excluded).
Rofil response: see Rofil response dated 23. April 2004
*
TUV 2. review: response accepted for the certification of the silicone filled implants.
But for the saline implants we will need a separate PDF, since there will be two separate
certificates. 7
c
-
•
1
7. Referenced attachment in the PDF for the chapters “intended use”, ‘product descnption” and
“all standards applied” is missing.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: open,
the PDF is a stand alone document and overview e.g. for the certifier and for the audit of a
competent authority. Therefore all applicable and relevant information need to be included into
the PDF or, directly attached to the PDF (maximum few sheets).
Just a reference in the PDF to the attachments of the technical documentation is not sufficient.
Rofil response: see Rofil response dated 24. May 2004
TUV 3. review: closed, but could be improved
Actual revision of the PDF should be used in the future (current revision of the PDF form
sheet is Rev. 4).
8. A legend of the abbreviations e.g. IMGHCLSII should be included.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: open,
Please send in revised PDF with correct codes.
Rofil response: see Rofil response dated 24. May 2004
TUV 3. review: closed
Printing Order
Design Dossier checklist-GB.doc
Rev.2; 2002-08-05
page 3 of 5
Design Dossier
Deviation Report
TÜVRheinland Product Safety GmbH
TÜV
Untemetiniensnippe
PJV RhefnId!Bertin-8rmid.nburg
Report No.: 21112263_OOl
Instruction for use
10. Because documents are partly not readable a readable IFU (overlapping copy of the gel pre
filled IFU has been provided) and labels shail be provided.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: open,
indeed we got the hard copy, but an overlapping copy (fIrst page) of the gel pre-filled IFU has
been provided. First column is half covered and therefore not readable. We need to compare
your instruction for use with the one from PIP.
Rofil response: see Rofil response dated 24. May 2004
TUV 3. review: closed
11. IFUs shall be revision controlled documents.
Rofil response: see Rofil response dated 23. April 2004
*TUV 2. review: response accepted for the certification of the silicone filled implants, but
please confirm the revision status Labels: 080216 and/or 3. April 2003?
Rofil response: see Rofil response dated 24. May 2004
TUV 3. review: closed
Labels
12. Saline filled breast implants are not part of this certification procedure. Please provide
examples for the labels of the pre-filled silicone implants.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: open,
at least a draft of the pouch pre-filled silicone implant label shall be included into the DD.
RoflI response: see Rofil response dated 24. May 2004
TUV 3. review: closed
Essential requirements
Design Dossier checklist-GB.doc
Rev.2; 2002-08-05
page 4 of 5
Design Dossier
TÜV Rhelnland Product SafetyGmbH
Deviation Report
TÜV
UntemeImensgruppe
10V RheinlandlBertin-Brandenburg
Report No.: 21112263_OOl
Risk Analysis
19. Table “The Risk Chart” (referenced in p. 14/14) is missing therefore the risk classification (risk
1 -x?) is not comprehensible.
Rofil response: see Rofil response dated 23. April 2004
*TUV 2. review: response accepted for the certification of the silicone filled implants, but
explanation of the risk range 1-15 is missing. What is the limit for measures?
4/./
‘Y
(/‘-
OEM-Contract
22. Clause 7 should additionally inciude: RMI has to be informed about any design changes of the
device and the impact on the device certification. RMI has to inform the notified body about any
essential design changes.
Rofil response: see Rofil resporise dated 23. April 2004
*TUV 2. review: response accepted for the certification of the silicone filled ïmplants, but
revised and signed OEM contract need to be provided to TUV.
Remark: The sentence “RMI has to inform the notified body about any essential design
changes”, was a general clarification and was not intended to be added into the OEM.
€. Zt,
‘.
•
For your information please find attached the “Answers and resolutions of EK-Med” # 920/03
for “Certification of OEM devices” clause 5 “contents of agreement” (file attached to the email).
The OEM contract should be checked.
End of 3. review
Design Dossier checklist-GB.doc
Rev.2; 2002-08-05
page 5 of 5
1O.2.e Dear
please find attached the 3. deviation report for the M-lmplants.
To speed up the process we decided to accept, that some corrections may be delivered after
time schedule until 21. June 04).
certification (marked with
“t”,
For the certification process the documentation deemed to be sufficient.
The release documents will be forwarded to the certification department for the certification process.
Best regards
1O.2.e
3. Deviation Report Silicone Breast lmplants
Additionally please find attached the Info for the contents OEM-contracts
EK-Med OEM3.9 A5 enqlisch.
1O.2.e
TUV Rheinland Product Safety GmbH
Am Grauen Stem, 51105 KÖln-PoIl
http://www.tuv.com/safety
Tel.: +49 (0)221
Fax: +49 (0)221
Mailto:
@de.tuv.com
Bel Fragen erreichen Sie unser Team vom Kunden-Service-Center unter 01803 112 112 oder [email protected]
In case of questions you will reach our team from customer service center +49 1803 112 112 [email protected]
169
—
10.2.e
Onderwerp:
WO: ROFIL documents part 2
Datum:
dinsdag 5 oktober 2010 17:55:17
Bijlagen:
tOLIoLatoLE
Dun:: one n roOf
Dnuumnet not
Duuun:nnl cdr
Document nut
Dun :::nnnl.uurf
art
Dear
,desr
10 2 e
here is part 2!
Freundliche GrUSe/Sest regards,
frledizinprodukte/Medical Devices
1 0.2.e
@de.tsv.com
Phone +49 (0
Fas +49 (0
TÜV Rheisland LGA Products Gmb[l
TIJV Rhe!s!asd Group
Am Grauen Stem 29
D-51105 Kö!n-Po!!
WWW.tus.com/safety
GeschbftsführungJsoard of Management
Nürnberg HR8 26013
8e! Fragen erre!chen Sie unser Team som Kunden-Service-Center inter 08005 888 770 oder [email protected]
In casa of geestions you Will reach our team from customer service ceeter +49 (0)911 650 5225 or [email protected]
Bitte denken Sie ae d!e Umwe!t, banor Sie diese Nachricht drucken.
Safore you print, please thiek about the enuironment.
o
“TUV Rimeinland LGA Products GmbH”
@de.tuv.com>
05.10.2010
15:16
10.2.e
An
@de.tuu.comv
Kopie
Thema
DD report
05.05.2004
(See attached file: Document.pdf)
Weitergeleitet von
/PS/DF/TUEV am 05.10.2010 17:25
1 0.2.e
“TUV Rheinland LGA Products GmbH
05.10.2010
15:17
n
10.2.e
m8mde.tuv.com>
Kopie
Thema
Statement
An
(Sea attached file: Docomest.pdfl
Weitergeleitet von
/PS/DE/TUEV am 05.10.2010 17:25
-
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TUV Rheinland LGA Producto GmbH
chide.tuv.com>
05.10.2010
15:18
As
1O.2.e
@de,tuv.comv
Kopie
Thema
Risk
Management
(Sea attached file: Docsment.pdt)
Weitergeleitet von
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TUV Rheisland LGA Producto GmbH’
ittde.tuv.csmv
1O.2.e
05.10.2010
15:10
As
1O.2.e
@de.tsv.com>
Kopie
Thema
report Design
Dossier
(Sea attached file: Document.pdf)
Weitergeleitet von
/PS/DE/TUEV am 05.10.2010 17:25
1O.2.e
c
TUV Rheinland LGA Prsducts GmbH”
@de.tuv,comv
05. 10.20 10
10:20
An
@de.tuv.comv
Kopie
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Auftrag
(Sea attached file: Document,pdfi)
Weitergeleitet von
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@de.tuv.com>
10 2 e
05.10.2010
15:21
1O.2.e
@de.tuv.com>
An
Kopie
Thema
Revision
Hiotory
(Sea attacired file: Document.pdt)
Weitergeleitet von
/PSJDE)TUEV am 05.10.2010 17:25
TUV Rheînland LGA Producto GmbH
<@de.tuv.com>
10.2.e
05. 10.2010
15:22
An
1O.2.e
@de.tuv.com>
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Product
information
(Sea aftached file: Document.pdf)
169.1
Rofil Medical International N.V.
Heudng 16 ‘ 4817 ZO Breda “ The Netherlands
T -31 (0)76 5315670
F +31 (0)76 5315660
1 ww.rofiIcom
E [email protected]
.-
Medical Devices TÜV Rheinland Product Safety
Attn:
Am Grauen Stem
1O.2.e
51105 Cologne
Germany
1O.2.e
Breda, 24/05/04
Ref.: 04.441 .TLJtl
Subject: Report No.: 211 12263_OOl
Dear
1O.2.e
Below you will find my reply to the points marked in red on the report with the above
number, 2. review. 1 hope 1 have now understood well what you require.
3. 1 have sent the PDF form on May 12 by fax, with the codes of all models filled in
and their translation. Is it now accepted?
5. The revision status of each document sent to the TÜV are the following;
Essential Requirements: 280404
Risk Analysis: 240404
Label: 030403
Instruction for Use: 020201
PIP Certificates: 250304
M-lmplants Statement: 230404
Draft EC Declaration of Conformity: 230404
Labels: 240504
-
-
-
-
-
-
-
-
7. 1 am sending you again the PDF form, this time with the “intended use” and the
“product description” filled in. 1 am sending also the signed list of standards as annex,
following the instructions of the form.
8. The legend of the abbreviations was sent in the PDF form on May 12. They are
again included in the attached PDF form.
10. 1 am sending you an original of the instructions for use.
11. The revision status of the label is indeed 030403.
THE
BEAUTY
PHILOSOPHY
12. 0fl the pouch of the silicone there are 4 labels applied: 1- the identification label
which you already have; 2- Three patient record labels which 1 am sending you now;
3- The bar code label which 1 am sending you. These are all the labels used. All the
labels are applied on the pouch. The outer box has a window. Through that window
the identification label can be seen. Of course the outer box has also some text
which mostly is repeated on the labels 1 am sending you.
1 had expected that the certificates would already be here but that is not the case yet.
Or did 1 misunderstood your E-mail and the red points had to be solved in order for
the certificates be sent?
Best regards,
:.
urT111...
‘ternational NV
1 O.2.e
Regulatory Affairs Manager
THE
BEAUTY
PHILOSOPHY
Design Dossier
TüVRheinIand ProductSafetyGmbH
Deviation Report
TÜV
Unfemelitnenzgruppo
113V Rh&nlandîBerln-Brandenburg
Report No.: 21112263001
Product name:
Mammary lmplants
Type(s)/Model(s):
IMGHCLS-S: silicone, smooth, high profile
IMGHCTX: silicone, textured, standard or high profile
[IMPHYTX: sahne, textured, standard or high profile (to be
clarified)]
IMREGTX: natural shape, textured
IMGHCTX-AL: anatomical left, textured
IMG HTCX-AR: anatomical right, textured
Info missing: volume: xx to xx cc (depending on profile)
Product group:
Mammary Implants
Legal manufacturer:
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda the Netherlarids
OEM-Product:
yes
Lino
Manufacturing
facility:
Poly Implants Protheses
337, Avenue de Bruxelles
83514 La Seyne S/M Cedex
Sterilization facility:
Information available in the file of:
Poly Implants Protheses
337, Avenue de Bruxelles
83514 La Seyne S/M Cedex
Design Dossier file:
M-lmplants
Date:
9.04.2004 (first submission)?
Revision:
Info missing
DepartmentlGroup:
Regulatory Affairs
1O.2.e
Author:
1O.2.e
Date
Design Dossier checklist-GB.doc
Name Reviewer 1
Rev.2; 2002-08-05
Signature Reviewer 1
page 1 of 6
Design Dossier
Deviation Report
TüVRheinland Product Safety GmbH
TÜV
Untemehmensgruppe
TÛV RheinIand!BerIin-Brndenburg
Report No.: 21112263_Ool
Date of TUV Review:
Date of Rofil Response:
Date of TUV 2. Review:
16. April 2004
23. April 2004 (received at TUV 29. April 2004)
05. May 2004
Please find in the following our preliminary numbered findings to the provided design dossier
documents:
Responses to each deviation can be inciuded into this document. Required documents shali be
provided.
Not numbered findings are remarks or hints for improvement or clarification.
The marked deviations “t” in the 2. TUV Review are accepted for certification but revised and
missing documents need to be provided until 21. June 2004
General
1. A device history including a brief device description (e.g. smooth, micro, normal textured, sizes,
volumes, shelf life, packaging ...) and a statement whether anything has been changed from
the original certified devices should be included.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: closed
2. A process flow chart or description should be provided illustrating the tasks and procedures of
RMI (e.g. if applicable packaging, labeling, shipment) including a reference to the relevant
procedures.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: closed, but could be improved
A concordance matnx including the certified PIP devices (naming see certificate) and
naming/renaming of the private label manufacturer RMI should be provided.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: open,
In our understanding Rofil uses identical codes as PIP for their products. Please send in
corrected PDF.
4. A draft of the “Declaration of Conformity” is missing.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: closed
A design dossier (DD) name and/or identification number is missing. Additionally for traceability
a revision number of the DD should be inciuded.
Documents shali be revision controlled.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: open,
reterenced revision file with revision status of alJ documents shali be provided.
Please provide “date of production” (version number) of the DD.
Design Dossier checklist-GB.doc
Rev.2; 2002-08-05
page 2 of 6
Design Dossier
Deviation Report
TüVRheinland Product Saf,ty GmbH
TÜV
Untemehmensgruppe
10V RtieinIancdBedin-Brndenburg
Report No.: 21112263_Dol
•
To improve review process and better traceability the design dossier should be structured into
sections.
•
Take into account that the saline filled breast implants of PIP are not certified yet, therefore they
are not subject of this certification procedure.
Product Description Form (PDF)
6. Saline implants from PIP are not certified yet and therefore not covered by the MDD
93/42/EEG, Annex 11.4 certificate. The “Product Description Form” (PDF) rieed to be revised
accordingly (saline implants should be excluded).
Rofil response: see Rofil response dated 23. April 2004
*
TUV 2. review: response accepted for the certification of the silicone filled implants.
But for the saline implants we will need a separate PDF, since there will be two separate
certificates.
Referenced attachment in the PDF for the chapters “intended use”, “product description” and
“all standards applied” is missing.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: open,
the PDF is a stand alone document and overview e.g. for the certifier and for the audit of
a competent authority. Therefore all applicable and relevant information need to be
included into the PDF or, directly attached to the PDF (maximum few sheets).
Just a reference in the PDF to the attachments of the technical documentation is not
sufficient.
A legend of the abbreviations e.g. IMGHCLSII should be inciuded.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: open,
Please send in revised PDF with correct codes.
Printing Order
9. Printing order should include all variants of devices or a reference to the concordance matrix.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: closed,
in our understanding Rofil uses identical codes as PIP for their products.
•
Take into account that the saline filled breast implants of PIP are not certified yet, therefore they
are not subject of this certification procedure.
Design Dossier checklist-GB.doc
Rev.2; 2002-08-05
page 3 of 6
Design Dossier
Deviation Report
TÜVRheinland Product Safely GmbH
.
TÜV
Untemetlmen3gruppo
TÜV Rheinland!Be,lin-Biandenburg
Report No.: 21112263_OOl
Instruction for use
jBecause documents are partly not readable a readable IFU (overlapping copy of the gel pre
filled IFU has been provided) and labels shail be provided.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: open,
indeed we got the hard copy, but an overlapping copy (first page) of the gel pre-filled IFU
has been provided. First column is half covered and therefore not readable. We need to
compare your instruction for use with the one from PIP.
11. IFUs shall be revision controlled documents.
Rofil response: see Rofil response dated 23. April 2004
*TUV 2. review: response accepted for the certification of the silicone filled implants, but
please confirm the revision status Labels: 080216 andlor 3. April 2003?
•
Saline filled breast implants of PIP are not certified yet, therefore the IFU for saline implants will not
be subject of the certification procedure yet.
Labels
Saline filled breast implants are not part of this certification procedure. Please provide
examples for the labels of the pre-filled silicone implants.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: open,
at least a draft of the pouch pre-filled silicorie implant label shali be included into the
DD.
13. CE-mark on the label (080216, dated 3.04.2003) and IFU need to be inciuded taking the
following form according the Annex XII of the MDD 93/42/EEC.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: closed
14. International standards (lSO 9001, EN 46001 expired!) need to be excluded from the labels
(080216, dated 3.04.2003). Only the CE-mark shall to be printed on labels and IFU.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: closed, but could be improved. In general quality standards should not be
printed on product packaging.
15. Labels shall be revision controlled documents.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: closed see deviation 11.
Design Dossier checklist-GB.doc
Rev.2; 2002-08-05
page 4 of 6
Design Dossier
Deviation Report
TüVRheInIand PmductSafetyGmbH
TÜV
Unt,mehmensgruppe
TOV RhelnlandlBertin-Brand.nburg
Report No.: 21112263_OOl
Essential requirements
16. It should be clearly distinguished which clauses of the essential requirements are in the
responsibility of the OEM manufacturer PIP e.g. biocompatibility (data located in the design
dossier by PIP) and which clauses are in the responsibility of the private label manufacturer
RMI e.g. Instruction for use, labels.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: closed, but could be improved
17. Where a numbered ER clause is divided into individual paragraphs (e.g. 13.3 a), b), ...; 13.6 a),
b), ...) the individual paragraphs need to be checked off (Yes/No/not applicable) or at east if
paragraphs are not applicable, this has to be marked of (e.g. 13.6 o) seems to be not
applicable).
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: closed, but could be improved
Risk Analysis
18. Conclusive statement about risks and benefits of the device in question is missing (see EN ISO
14971 clause 7 and 8).
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: closed
19. Table “The Risk Chart” (referenced in p. 14/14) is missing therefore the risk classification (risk
1-x?) is not comprehensible.
Rofil response: see Rofil response dated 23. April 2004
*TUV 2. review: response accepted for the certification of the silicone filled implants, but
explanation of the risk range 1-15 is missing. What is the limit for measures?
20. There are two possibilities of performing a risk analysis:
a) RMI submit a full risk analysis referring to each applicable clause of the EN ISO 14971.
1f RMI would like to perform a full risk analysis than e.g. risk estimation according clause C.2.
“Toxicological risks” and EN ISO 14971 “D.2” are missing in the provided document.
or:
b) RMI submit a reduced risk analysis and refers to the risk analysis of the OEM manufacturer.
RMI should define risks associated to the responsibilities and processes of RMI (e.g. labeling,
instruction for use, storage, shipment, ...).
Rotil response: see Rofil response dated 23. April 2004
TUV 2. review: closed, but could be improved.
Design Dossier checklist-GB.doc
Rev.2; 2002-08-05
page 5 of 6
Design Dossier
Deviation Report
t.
TÜV Rheinbnd Pmduct Safety GmbH
TÜV
Untemehmensuppe
TOV RheInIandIBertIn-Brandenburg
Report No.: 21112263_OOl
21. A risk analysis shail inciude the following steps:
a) The risks need to be specified and estimated.
b) Actions/procedures/appiled standardslcontrols etc. shali demonstrate how the individual risk
should/could be reduced.
c) A new estimation of the reduced risk.
Steps b) and c) are missing in the risk analysis.
Rofil response: see Rofil response dated 23 April 2004
TUV 2. review: closed, but could be improved
OEM-Contract
22. Clause 7 should additionally include: RMI has to be informed about any design changes of the
device and the impact on the device certification. RMI has to inform the notified body about any
essential design changes.
Rofil response: see Rofil response dated 23. April 2004
*TUV 2. review: response accepted for the certification of the silicone filled implants, but
revised and signed OEM contract need to be provided to TUV.
Remark: The seritence “RMI has to inform the notified body about any essential design
changes”, was a general clarification and was not intended to be added into the OEM.
23. OEM contract should list each of the relevant devices.
Rofil response: see Rofil response dated 23. April 2004
TUV 2. review: closed
•
For your information please find attached the “Answers and resolutions of EK-Med” # 920/03 for
“Certification of OEM devices” clause 5 “contents of agreement” (file attached to the email).
End of 2. review
Design Dossier checklist-GB.doc
Rev.2; 2002-08-05
page 6 of 6
Dear
l’m now back from vacation and reviewed the responses to the M-Silicone lmplants Design Dossier
10.1e together with
Just a remark concerning to your letter, dated 23. April 04; the additional
documents were requested, because the needed information was neither inciuded in the essential
requirement list nor in the OEM contract.
To speed up the process we decided to accept, that some corrections may be delivered after
certification.
But you need to address the red marked items. Especially you urgently need to send a revised and
corrected Product Description Form (PDF), because this will be the basis for our certification process.
Tomorrow you will received the draft certificates for your approval.
Please find attached our formal response to the identified deviation:
2. Deviation Report Silicone Breast lmplants
1f you have any questions, please just calI.
Best regards
10.2.e
Bereich Medizinprodukte / Medical Devices
TUV Rheinland Product Safety GmbH
Am Grauen Stem, 51105 Köln-Poll
http://www.tuv.com/safety
Tel.: +49 (0)221/
Mobil: +49 (0)f
Fax:
Mailto:L
1
‘
de.tuv.com
Bel Fragen erreichen Sie unser Team vom Kunden-Service-Center unter 01803 112 112 oder [email protected]
In case of questions you will reach our team from customer service center +49 1803 112 112 or [email protected]
169.2
Rof ii Medical International NV.
-eusing 16 ‘. 4817 ZB Breda
The Netherlands
T +31 (0)76 5315670 “ F +31 (0)76 5315660
6 [email protected]
1 wwrofiI.com
‘-‘S
M-Implants Statement
23 April 2004
g
M-Irnplants are sterile breast implants pre-fluled with high cohesivity silicone gel
intended to be used in plastic surgery for:
Breast augmentation: increasing the breast volume by implant insertion;
Breast reconstruction: after total or partial removal of the injured or cancerous
malnrnary gland.
Each implant is protected by a double packaging which guarantees the implant sterility
and a better asepsis during the manipulation conditions. From the outside packaging to
the implant, there is:
A transparent film in PE,
A box in PP,
An extemal blister in PETG with Tyvek® lid,
An internal bijster in PETG with Tyvek® lid,
High cohesivity gel pre-fihled breast implant.
An identification label as well as three self-aclhesive labels is applied on the extemal
bijster lid.
M-Implants pre-fihled with silicone consist of the following components:
1. Container: sterile and biocompatible envelope manufactured from medical grade
silicone elastomer;
2. Content: sterile and biocompatible high cohesivity medical grade silicone gel.
High cohesivity silicone gel pre-filled breast implants are manufactured in several
variants regarding:
1. Profile
1.1
Standard profile (S)
1.2
High profile(H)
1.3
Ultra high profile (UH)
1.4
Reconstruction profile (R)
1.5
Asymmetrical profile (AR or AL)
2. Surface
2.1
Smooth surface (LS)
2.2
Micro-textured surface (MX)
2.3
Textured surface (TX)
3. Volume
3.1
Several volumes: from 85-705cc.
The shelf-life of the product is 5 years.
L
THE
BEAUTY
PHILOSOPHY
The M-linplants pre-fihled implants are exactly the same as the previously CE-marked
produets. This inciudes the product labels and the instructions for use.
International BV
1O.2.e
THE
BEAUTY
PHILOSOPHY
Rofil Medical International N.V.
Reusing 16 4817 ZB Breda ‘ The Netherlands
T --31 (0)76 5315670 “ F -f31 (0)76 5315660
E rrni@rofil corn
1 wsw.rofiLcom
‘-‘
‘-‘.
Rofil Medical International NV
Heusing 16
4817 ZB BREDA
The Netherkinds
EC DECLARATION OF CONFORM1TY
medical devices
We hereby declare that the M-Implants, specified in the annexed product list, are covered by the ‘CE Marking of
Conformity Certificate’, regisiration number: ???, issued on ??? and delivered by TÜV Rheinland Product Safety
GmbH Am Grauen Stem, Köln, Germany, Notified Body Identification Number 0197, and conform to the
required technical documentation, in accordance with Annex II of the ‘EC-Directive”, the Council Directive
93/42/EEC of 14 June 1993, concerning medical devices.
—
We declare that the M-Implants, fauing within Class III, meet the provisions of the EC-Directive which apply to
them.
Additionally, this declaration is supported by the Quality System of the manufacture in accordance with ISO 9001:
2000 and EN-ISO 13485: 2003 certified by TÜV Rheinland Product Safety GmbH.
This Declaration of Conformity covers M-Implants as specified in the annexed product list and is valid for
products bearing the CE mark and manufactured at the following site:
P.I.P.
337, Avenue de Brurelles
83500 La Seyne Sur Mer
France
1O.2.e
Annex: Product list
THE
BEAUTY
PHILDSOPHY
Annex to the Declaration of Conforiuity (Product list)
Rofil Medical International BV
Heusing 16
4817 ZB BREDA
The Netherlands
PRODUCT LIST
(M-lnp1ants)
Product name
Anatomical High Cohesive Mammary Iniplant
THE
BEAUTY
PHILOSOPHY
169.4
Design Dossier report
for
amen dments MDD
TUV
TÜV Rheinland Group
ReportNo.: 21112263_004
A. General
Product name:
IMGHC silicone breast implant
Type(s)!Model(s):
See filled in PDF
Product group:
Mammary Implants
Legal manufacturer:
OEM-Product:
Rofil Medical Nederland B.V.
(formerly: Rofil Medical International N.V.)
Heusing 16
4817ZB Breda
Netherlands
yes
Eno
Man ufactu ring
facility:
Poly lmplants Protheses (PIP)
337, Avenue de Bruxelles
83514 La Seyne SIM Cedex
Sterilization facility:
Information available in the file of:
Poly lmplants Protheses (PIP)
337, Avenue de Bruxelles
83514 La Seyne SIM Cedex
TUV Rheinland
Certificate Number:
10 60008171 0001
Other Certificate
Numbers:
.1.
Design Dossier file:
M-lmplants
Date:
18.07.2007
Revision:
18.07.2007
DepartmentlGroup:
Regulatory Affairs
1O.2.e
Author:
1O.2.e
Zr’:7
7
.
Date
/J)
Name Reviewer 1
Not applicable
Date
Name Reviewer 2
Design Dossier report for amendmenis MDD-GB.doc
Signature Reviewer 2
Revision 2; 2006-01-01
page 2 of 5
Design Dossier report
for
amendments MDD
TUV
TÜV Rheinlarid Group
ReportNo.: 21112263_004
B. Product categorization and choice of procedure
The “Mammary lmplants” (IMGHC) devices are silicone pre-filled breast implants
used in plastic surgery for breast augmentation or breast reconstruction.
All breast implants are classified as class III medical devices in accordance with
Directive 20031121EC of 3. February 2003, Article 1 “By way of derogation from the
rules set out in Annex IX to Directive 93/42/EEC, breast implants shali be
reclassified as medical devices falling within class III”.
The testing was performed by means of an assessment of the documents on the
basis of the Directive 93/42/EEC.
C.
Changes to the licensed product
The assessment was peilormed by means of an examination of the documents,
which were provided by Rofil Medical Nederland B.V. (formerly named: Rofil
Medical International N.V.).
Reason for the assessment:
In June 2007 Rofil Medical International N.V. (RMI) applied for the change of the
company name from Rofil Medical International N.V. (RMI) into Rofil Medical
Nederland B.V. (RMN).
In this report both company names (RMI and RMN) are used, but should be
considered to be the same company.
For the above mentioned product the TÜV Rheinland Product Safety GmbH design
dossier certificate ID 60008171 0001 was issued.
RMI has been assessed to Annex 11.3 of the Medical Device Directive 93/42/EEC by
TÜV Rheinland Product Safety GmbH (certificate # HD 60009358 0001). The scope
of the certificate inciudes the device in question.
Design Dossier report for amendments MDD-GB.doc
Revision 2; 2006-01 -01
page 3 of 5
Design Dossier report
amendments MDD
TUV
TÜV Rheïnland Group
ReportNo.: 21112263004
D. Summary
The change of the company name does not require a review of the design or
manufacturing (mci. sterilization) process.
An example of an updated label, Instruction for use and declaration of conformity
inciuding the new company name was reviewed. In addition the revision history for
the Design Dossier was sent and a printing order for the certificate was provided.
The documents are found to be in compliance with the requirements of the
directive.
Therefore it is recommended to revise the Directive 93142/EEC Annex 11.4 approval
of the Directive 93/42/EEC (ID 60008171 0001) and to include the new company
name.
All other certificates issued by TÜV Rheinland Product Safety GmbH for Rofil will be
rewritten to inciude the new cornpany name (RMN). Please refer to the TUV
Rheinland Product Safety GmbH report no 21104600_008 for the 3. surveillance
audit.
All of the above mentioned verifications have been performed. Due to this,
evidence for the compliance of the mammary implants to the requirements of the
medical device directive has been provided.
E. Important Note
Modifications to the Product may only display the CE mark after testing and
approval by the notified body, TÜV Rheinland Product Safety GmbH.
Design Dossier report for amendments MDD-GB.doc
Revision 2; 2006-01-01
page 4 of 5
‘
i
Revision
Ilistory
da ed
18.07.07
Revision
.
Dossier
Company
name
Description
of Change
na
Product
Description
Re-evaluation necessary
Design Dossier report for amendments MDD-GR.doc
name of the legal
;“manufacturer
Change f the.
Trade-Name
Additional Model
Manufactunug
Facility
Maunfacturing
cess
6
Pr
Sterilization
ProcessfFacility
L
Packhg
:
Matenal Device)
‘
Change of..:
=
F. Extension Checklist
ReportNo.: 21112263_004
na
ERChecklist
amendments MDD
Design Dossier report
for
=
na
Biocompatibility
Revision 2; 2006-01 -01
na
Hazard
Analysis
na
Clinical
Data
Re-evaluation to be considered
x
Labeling
na
page 50f 5
na
Sterilization ‘
1 Electrical
Validation
TÜV Rheinland Group
X = Evaluation performed
1 Mechanical/
TÜV
169.5
Auftragsdaten
Auftraggeber
Auftragskennwort
Auftragsnummer
Auflragswert
Auftragsbeginn
Auftragsabschluss
Mitarbeiter
ROFIL MEDICAL
Charige legal Manuacturer name RMI into RMN
1030374
1.650,00
02.07.2007
31.07.2007
Kostenstelle
303
1O.2.e
weitere
Proiektm itarbeiter
verantwortlicher
Proiektmitarbeiter
Projektkennwort
Review/Certification
Notiz:
26.06.2007 / Ute Tiby/PS/DEITUEV
100% Vorkasse 31701054
—
erfaIt am:
erfa(t von:
1O.2.e
Berichtsnummer
Servic’
21104600-007
18134
—
26.06.2007
Ute TIbyIPSIDE/TUEV
1 O.2.e
0€? ?(c
S/DE[tUEV
1O.2.e
29.06.2007 10:19
An DE-PS-GF3.3-ProjectMgmt
Kopie
Blindkopie
Thema ZAF bezahit, Rofil Meclical
Hallo zusammen,
Kunde: Rofil Medical
Kd-Nr.: 452431
ZAF-Nr. 31701054
Auftrag-Nr. 1030374
ZAF bezahit am 28.06.07
Mit freundlichen GrüBen/Best regards,
1O.2.e
FinanceiAccounting/AdministratiOfl
__
NO. 7043
NUHL MD1CAL Wl) V 31705315550
1. JUP& ?UU7 15:17
Order Fax
From:
1O.2.e
Rofil Medical International NV
SmederlJstraat 2
4817 ZB Breda
÷31J
Tel:
+3111
Fax:
E-MalI:
VAT Regi5kation:
Niederlande
Cust.No.: 0000452431
To:
TÛV RheIn land Product Safety GmbH
Sales and Marketing
Number of pags: 1
00184049KF&96.1 dted 0t06.2001
Quotatlon Nos:
tional NV.)
Chango leg& ManLllacturer name RMI (Rolfi Medlcal Interna
Product
Into RMN (RofU Medlcal Natlonal N.V.)
Dear
ea are descrlbed In the ebove
The order we are placing i marked in the below hok box. All Servic
ited and!or TÜV Rhelnland
acxred
to
tracted
subcon
be
may
the
testing
of
menlioried guotalion. Parts
Prodt.ct Safety GmbH listed laboratorlea.
it)
We reglstered the order under the following order no.
it’,
1
-
[EJ
Revlew, Certificatlon
21.022007)
(additlonal service to the quotatlon nou: 001 B-3049Faa!170 dated
Certificatlon and Production Fadilty Inspection
We would like to order a productfon facility inspection
1=1 at the same me es testing
Q before tesling
The address of our productiori facility Is:
Company:
Street:
Postcode:
0 after teating
Contact:
Tel:
Fax
E-mail;
Country
Vee, we would like to make use of the TUVdotCOM Service. Please contact us.
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Yee, we like to order TUVdo1COM Service doscribed In section number
of the quotation
We have further queries about your offer or service Please give me a cel!:
MrIMs
TeL;
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Yours falthfully,
1O.2.e
11 Medical International NV.
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P, 1
OS
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2007
5:32pm
Bio
Top
Medical
071
5280115
Roffi Madical Nedrfand BV.
ROFIL
He.sing 16 .4817 ZB Bre ‘The Nthr)and5
t
T#31 (0)76 5315673
+3 (0)76 5315660
rm@ro1iI,corn - ww,,rotiI.<om
Rofil Medical Nederland BV
Heusingi6
4817Z8 Breda
The Neherlands
DECLARATION OF CONFOPM1TY
medical devices
We hereby declare that the product M-Implanls, conform to the required thnica1 dccumentation, in accordance
wilh Annex 11 (Full Quality Assurance) of the ‘EC-Dizectivc”, the Council Directive 93/42/EEC of 14 June 1993.
concerning medical devices. “EC Design Examination Certificate” (fl) 60008171 0001) issued by the Notified Body
TÜVRhein!nd Pii,duct Safety GmbH (0197), Cologne, Gemiany.
In addition, we ensuie and declare that the disttibuted CE marked producta, as nrnioned and falling within Claas
H1 meet the provisions of the EC-Directive, which applyto tlaeni.
This declaration is supported by the Quaiity Systern certification based on the harmonized standanis ISO 90011 ISO
13485, Qualily Systein Cerdficate with registration nuniber SY 60014115 0001/SX 60014114 0001 issued on
30/3/2006 and ddiverec1 by TÛV Rheinland Product Safety GnibH.
Mariufcturin site:
Pc?y !mplantProlhe.se
337, Av. De linixelles
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France
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13.07.2007 17:12
de.tuv.com>
.
biotopmedicaI.nI>, “Rofil Medical
International NV’ <[email protected]>
Blindkopie
Thema RE: Antwort: RE: Mammary lmplants Design Dossier Name
change RMN
1O.2.e
Dear
With this e-mail you receive the changed labeling of the M-implants:
Labeling box
Instructions for Use
Package envelope
Follow up slip
Implant bearers identity card
Implantation slip
-
-
-
-
-
-
Next wednesday 1 will send you the revised revision history together with the Incident Overview
Listings.
Kind regards,
1O.2.e
—-—Oorspronkelijk bericht
Van:
[mailto
cde.tuv.com] 1O.2.e
“li 2007 14:32
-
1O.2.e
1
““t: RE: Mammary Implants Design Dossier Name change RMN
1O.2.e Dear
thank you for the response.
1) Revision history isfortracking purposes of the Design Dossierand an overviewofailvalid
documents.
Old revised documents need to be archived.
would like to remember that TUV should be notified each quarter a year of
2)
incidents/rieard incidents for M-Implants (refer to RMI correction to deviation 4).
3) We just got the Info from the SNCH, that the certificates of Procytech are suspended.
Therefore we currently cannot recommend to include this supplier into the scope of the ISO
13485:2003 certificate for RMN (1 have informed
Best regards
1O.2.e
biotopmedicaI.nl>
1O.2.e
06.07.2007 17:33
An
Kopie
c
de.tuv.com>
•biotopmedjcaI.nI>
Them RE: Mammary Implants Design Dossier Name change
a RMN
10.2.e
Dear
Thank you for your comments on the Product Description Form. 1 have corrected the form and
will fax it to you today, together with the new Declaration of Conformity.
We are currently working on the labels and IFIJ, which 1 will send to you next week.
Could you please explain to me what you mean with the revision history of the design dossier?
1 don’t understand the question.
Kind regards,
10.2.e
Oorspronkelilk bericht----Van:
âde.tuv.comJ
[mailto:
10 2 e
Verzonden: donderdag 5 juli 2007 14:59
Aan:
Onderwerp: Mammary Implants Design Dossier Name change RMN
Dear
dear
10.2.e
few questions arose after review of the provided documents (Mammary Implants Design
Dossier)
a) Product description Form (PDF)
1)chapter Product name: model IMGHC-TX-H deems to be missing (compare to current
certificate)
2) chapter Application for conformity Assessment for EC Design Examination: Date
missing (14.06.07)
...
...
b) For review, please provide updated Label, IFU and declaration of conformity for the breast
implants.
Please provide a revision history of the design dossier (please refer to my previous email
dated 1.6.2007).
1 would be pleased, if you can response asap.
Best regards,
10.2.e
Cellular +4 (b)
Fax +49 (0)221)
TÜV Rheinland Product Safety Gmbl-I
TUV Rheinland Group
Am Grauen Stem
51105 Köln
http://www.tuv.com
1O.2.e
KöIn HRB 25960
Bei Fragen erreicheri Sie unser Team vom Kunden-Service-Center unter 01803 112 112 oder
[email protected]
In case of questions you will reach our team from customer service center +49 1803 112 112
or [email protected]
Bitte denken Sie an die Umwelt, bevor Sie diese Nachricht drucken.
Before you print, please think about the environment. botpdl IFU.pdl package envelope.pd[ Follow up.pdF
implant bearers.pdf implentation slip.pdt
05 mrt 2007
5:lSpm
Bio
Top
Medical
071
5280115
p.l
169.7
Rofli Medical International N.V.
Snzderijtrut 2’ 4t4 DB Btda zThe Netherlauds
F4-31 (0)765317701
T-f31 (0)765317959
Message by Telefax
10.2.
Corn pany
Fortheattentionof
Fax nurn bar
Nuniber of pages
Subject
Date
Reference
Dear
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TÜV Rhelnland
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As indicated in my e-mail of today, 1 am faxing you the following documentation:
Declaration of Equivalence regarding the trade names of
and
-
M-implant outer packaging
M-irnplant Instructions for use
M-irnplant Implantation slip
M-irnplant Follow up slip
M-irriplant bearer’s identity card
-
-
-
-
-
buiten Wob verzoek
Kind regards,
lical International N.V.
—
—
10.2.e
It this transmission has not been correctly received, please Inform us immediately.
Tel.: +31 (0)76 5317959 Fax: +31 (0)76 5317701
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Smederjstraat 2
4814DB Breda
The Netherlands
DECLARATION OF CONFORMITY
medical devices
We hereby declare that the product M-Implants, conform to the required technical documentation, in accordance
with Annex II (Full Quality Assurance) of the “ECDirective”, the Coundil Directive 93/42/EEC of 14 June 1993,
concerning medical devices. “EC Design Examination Certificate” (ED 60008171 0001) issued by the Notified Body
TÜV Rheinland Product Safety GmbH (0197), Cologne, Germany.
In addition, we ensure and declare that the distributed CE marked products, as mentioned and faLling within Class
III, meet the provisions of the EC-Directive, which apply to them.
This declaration is supported by the Quality System certification based on the haniionized standards ISO 9001! ISO
13485, Quality System Certificate with registration nuinber SY 60014115 0001/SX 60014114 0001 issued on
30/3/2006 and delivered by TÛV Rheinland Product Safety GmbH.
Manufacturing site:
Poly Implanl Proihese
337, Av. De Bruxelles
83507 La Seyne sur Mer
France
Breda, 28 February 2007
1O.2.e
President
10.2.e. (gehele document)
170
pagina 1 van 2
IGZ
Van:
Verzonden:
donderdag 7 oktober2L .J 14:15
Dienstpostbus IGZ Zuidwest
Aan:
Onderwerp:
FW: conceptverslagen inspectiebezoek / P hiloderm Aesthetics BV.
Urgentie:
Hoog
Opvolgingsmarkering: Opvolgen
Markeringsstatus:
Voltooid
Bijlagen:
Brief Min. VWS
Graag aan melding
Van:
Verzc
doc
Philoderm én Rofil Medical International NV hangen.
ophilodermaesthetics.com)
) 13:15
Onderwerp: FRe: conceptversiagen inspectiebezoek Philoderm Aesthe
tics B.V.
1
Urgentie: Hoog
Geachte
Bijgaand en m.b.t. bovengenoemd onderwerp zend ik u een afschrift van
ons schrijven dd. heden welke ik vandaag tevens per
post aan u verzond.
in het vertrouwen u hiermee te hebben geïnformeerd, verblijf ik,
Met vriendelijke groei,
Philoderm Aesthetics BV.
Van:
Verz_______
oktober 2010 16:30
Aan:
hiiodermaesthetics.com; info
Onderwerp: concepterslagen inspectiebezoek
[N!z3
)igz.nlJ
4ZiT
3Ç
Geachte
Hierbij ontvangt u de conceptverslagen van ons inspectiebezoek van
23 september 2010 per mail. Deze
verslagen zijn u ook per normale post verstuurd. Ik wil u verzoe
ken er zorg voor te dragen dat
deze verslagen ook ontvangt.
Hoogachtend,
inspecteur
Inspectie van de Gezondheidszorg
Ministerie van Volksgezondheid, Welzijn en Sport
Wflhelmina van Prusenwea 52 1 2595 AN Den Haag Kamer
1
Postbus 90700 t 2509 LS Den Haag
T +31 70
F +31 70
M +3’
3041
-
1
N.igzn[
Voor een gerechtvaardigd vertrouwen in verantwoorde zorg
07-10-201()
pagina 2 van 2
Dtbricht kan inforniatis bevatten die niet voor u is bestemd. indien u niet de geadresseerde bent
of dit bericht abusievelijk aan u is toegezonden, wordt u verzocht dat aan
de afzender ie melden en het bericht te verwijderen De Staat aanvaardt geen aansprakelijkheid
voor schade, van welke aard ook. die verband houdt met risicos verbonden
aan het elektronisch verzenden van berichten.
This massage may contain information that is not intended for you. 1f you are not the addressee
or if this message was sent to you by ruislake. you are requested to inforrfl
the sender and delete the message. The State accepis no liability for damage of any kind resutting
from the risks ehererit in the etectronic transmission of messages.
07-10-2010
170.1
10.2.e. (gehele document)
Inspectie voor de Gezondheidszorg
ta.v.
Postbus 90700
2509 LS DEN HAAG
Breda, 7 oktober 2010
Betreft
Philoderm Aesthetics B.V. 1 Rofil Medical Nederland B.V.
In goede orde ontving ik zowel per e-mail als per post de door u opgestelde
conceptverslagen d.d. 5 oktober 2010 m.b.t. het inspectiebezoek van u en uw collega
)p 23 september 2010 ten kantore van Philoderm Aesthetics BV. te Breda.
•
Ik heb beide conceptverslagen doorgenomen en tevens besproken met
Ter zake treft u per conceptverslag onze op- en/of aanmerkingen en aanvullingen aan.
1. CONCEPT-VERSLAG PHILODERM AESTHETICS B.V.:
Bladzijde 1:
Laatste alinea: ‘U hebt verzekerd dat geen medische hulpmiddelen van Rofil aan de
voorraad van Philoderm zijn toegevoegd en/of zijn afgeleverd door Phii’oderm’.
Deze weergave is niet volledig:
heeft tevens bevestigd op uw specifieke
vraag ter zake de in de voorraad van Rofil aanwezige Pip-protheses dat deze noch aan de
voorraad van Philoderm zijn toegevoegd noch op enige andere wijze zijn gedistribueerd
binnen de EU.
Bladzijde 2:
Buiten
Wob-verzoek
Alinea 3, laatste zin: ‘Deze waren volgens u nog niet beschikbaar’.
Aanvulling: aangezien deze protheses nog niet in de handel zijn gebracht respectievelijk er
nog geen voorraden aanwezig zijn.
Alinea 5: ‘U heeft een ruimte (vroeger was dit een cleanroom) waarin u etiketten van
lotnummer en houdbaarheidsdatum voorziet’.
Aanvulling: (..) houdbaarheidsdatum en eventueel (voor leveringen binnen de EU) van een
CE markering voorziet.
Buiten Wob-verzoek
Bladzijde 3:
2. CONCEPT-VERSLAG ROFIL
MEDICAL NEDERLAND B.V.
MEDICAL
INTERNATIONAL
N.V.
EN
ROFIL
Bladzijde 1:
Alinea 2: ‘De aanleiding van dit inspectiebezoek was dat de Franse toezichthouder
AFSSAPS hij Poly Implant Prothese (PIP) een ernstige afwijking in de samenstelling van de
i,nplantaten heeft geconstateerd’.
Ten aanzien van deze weergave merken wij het volgende op.
bekencFr
ieeft tijdens onze bespreking u meegedeeld dat dit voor zover hem
standpunt van de AFSSAPS is maar uw interpretatie.
Voor zover
bekend, heeft de AFSSAPS gedurende het door haar
ingestelde en nog lopende onderzoek naar de PIP-protheses tot op heden geen bijzondere
risico’s voor de volksgezondheid ter zake geconstateerd. Wel heeft men geconstateerd dat
de betreffende silliconen-protheses ‘zweten’ en onderzoekt men momenteel de gevolgen
ieeft ter zake van dit ‘zweten’ opgemerkt dat dit inherent is aan
daarvan.
het gebruikte materiaal (siliconen) en dat dit een feit van algemene bekendheid is binnen de
branche.
Bladzijde 2:
Alinea 1: ‘Deze praktijk van PIP vond u verontrustend, want u vroeg zich af of voor dergelijke
prijzen wel met de juiste materialen gewerkt kon worden. U heeft in een reactie daarop eind
2008 een voorziening in de boekhouding laten treffen om de overgebleven voorraad in haar
geheel af te schrijven’.
heeft slechts meegedeeld dat hij zich heeft
Deze weergave is niet juist.
verbaasd over het gegeven dat PIP ver onder de marktprijs haar protheses verkocht op
markten, onder meer in Zuid-Amerika. Dit heeft hem vervolgens ertoe genoodzaakt eind
2008 een boekhoudkundige voorziening te treffen ter zake van de overgebleven voorraad
protheses. Immers de prothese-markt stortte volledig in door het ‘dumpen’ door PIP van
protheses in de markt ver onder de (kost)prijzen van de M-implants-protheses.
Alinea 1: ‘Deze containers zijn daarna door een professionele afvalverwerker afgevoerd’.
Aanvulling: afgevoerd en ter vernietiging aangeboden.
Alinea 4: ‘U heeft niet gevraagd naar het percentage van implantaten van P1P dat
scheurden, want u vond dat u daar geen reden voor had’.
ieeft meegedeeld dat hij daar geen reden toe zag aangezien
Aanvulling.
het percentage scheurende implantaten binnen de reguliere en binnen de branche daarover
bekend zijnde bandbreedte viel en tevens dit vooral gevallen betrof bij één chirurg.
Bladzijde 3:
Alinea 1: ‘U bent van mening dat het niet mogelijk is om zon vervalsing lang vol te houden.
Aan de andere kant was u er van op de hoogte dat PIP sinds 2007 in een vorm van
surseance van betaling verkeerde. U acht het tnogelijk dat financiële druk het bedrijf tot deze
misstap heeft gedwongen’.
Deze weergave is niet volledig en dient naar onze mening te worden gewijzigd in:
U bent van mening dat het niet mogelijk is om zon vervalsing lang vol te houden gelet op het
feit dat er voortdurend leveringsbewi/zen met daarin de vermelding van de juiste
grondstoffen dienen te worden overlegd. Aan de andere kant was u er via via van op de
hoogte dat PIP sinds 2009 in een vorm van surseance van betaling verkeerde, Acht het
mogelijk dat welficht financiële druk het bedrijf tot deze misstap heeft bewogen. U was in
ieder geval buitengewoon verrast toen u via via deze geluiden uit de pers en uit de markt
Vernam.
Alinea 2: ‘U heeft in de gebruiksaanwijzing van M-lmplants onder andere waarschuwingen
over scheuren op laten nemen.
Aanvulling: zoals ieder fabrikant gewoon is te doen.
Alinea 3: ‘Bij de rondgang door het bedrijf hebben wij archiefdozen aangetroffen (...)‘
De term aantreffen suggereert enige verassing / iets onoorbaars. Wij stellen voor deze
formulering te wijzigen in: Bij de rondgang door het bedrijf hebben wij tevens geconstateerd
dat de administratie van Rofil (boekhouding. kwaliteitscontrole, correspondentie enz.) over
de periode 2000 tot 2009 (gearchiveerd) ten kantore van Philoderm Aesthetics B.V.
aanwezig is.
3. SLOT
Graag ontvang ik van u beide concept-verslagen een tweede concept met daarin de
hierboven vermeldde wijzigingen respectievelijk aanvullingen onzerzijds.
In het vertrouwen u hiermee te hebben geïnformeerd, verblijf ik,
Met vriendelijke groet,
Philoderm Aethetics BV.
UK VIGILANCE REPORT UK-2010-10-06-09
2 PTP-Silicone Fili
1O.2.e. (gehele document)
174
4 kk,rde
Centraal Kantoor Utrecht
1 1 flh/T 7fllf)
&I U
_Dienstpostbus IGZ Loket Utrecht
Verzonden: donderdag 7 oktober 2010 15:1
2
Aan:
_Dienstpostbus IGZ Utrecht
Onderwerp: FW: UK VIGILANCE REPORT UK2010-10-06-092 PlP-1Itcon Filed-Oet
Bijlagen:
UK-20 1 0-1 0-06-092 PIP-Silicone Filled Gel Brea
st (mplants.pdf
IrriAkÔrnn
FE
PARW
Van:
Graag inboeken.
Let op: betreft de PIP-implantaten!!
Met vriendelijke groet,
Inspectie voor de Gezondheidszo
rg
IGZ-loket
Postbus 26801 3500 GRI Utrecht
T 088-1205000
btigni
gL.ni
mhra.gsi.gov.uk}
17:56
ages.at; [email protected]’
hs.moh
__)sukl.sk;
Pages.at;
jazmp.si;
wiv-isp.be
uropa.eu;
e.fr;
JKI
..
_M0-10-06-092 PIP-Silicone Filled Gel Brea
st lmplants
Dear all,
COMMERCIAL-IN-CONFIDENCE
NOTJFICATION OF VIGILANCE REPORT
UNDER THE MEDICAL DEVICES DIRECT
IVE
93142!EEC
Article 10 of the Medical Devices Directive
(931421EEC) requires all Competent
Authorities in each EC Member State (inci
uding the EFTA Member States
participating in the EEA Agreement) to infor
m the Commission and other Member
11-10-2010
dci.
UK VIGILANCE REPORT TJK-2010-10-06-0
92 PIP-Silicone Filled Gel Breast 1...
pagina 2 van 2
States of incidents for which relevant mea
sures have been taken or are
contemplated.
1 attach a vgilance notification. Any gen
eral enguiries_should be made to the MHR
A
Adverse Incident Centre (Telephone: +44
Fax:
+44
20
7084
---1
any technical ençtuiries relatrng to this notificati
on should be made
(+44
«UK-2010-1O-06-092 PIP-Silicone Filled Gel
Breast lmplants.pdf»
Adverse Incident Centre
Medicines & Healthcar
iwcts Regulatory Agency
Direct Line: 020 7084
AIC Hotline: 020 708
Rease consider the environment befo
re printing this erna ii
MHRA moves from Monday 18 October to:
Medicines & Healthcare Products Regulator
y Agency
Adverse Incident Centre
4 Floor
151 Buckingham Palace Road
London SWIW 9SZ
This email and any files transniitted with It
are confidential. t YOU are not the intend
ed recipient, any reading, printing. storage
disciosure, copying or any other action taken
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11-10-2010
NATIONAL COMPETENT AUTHORITY REPO
RT
This form should be used for the exchange of
medical device information between natlonal
Competent
Authorities and the Euiopean Commlssion only.
Completed forms should not be released to
the public.
1. Is this report confidential?
Yes [1 No (Xi
Reference and Reporter Data
2. NCA report ref. no.:
3. Local NCA reference no.:
4. Related NCA report nos.: (if any)
UK-20 10-10-06-092
2010/003/030/081/019
5. Manufacturer Ref/FSCA no.:
N/A
8. Tel: +44 207 084
Device Data
1 1 a. Generic name! kind of device:
Slicone gel l9lled breast implant
12. Nomenclature id: GMDN
6. Snt hv
(Nn,e and Organization)
dledicines &
T[ealthcare products Regulatory
Agency
9. Fax: +44 20 7084 3109
if different from 6)
10. E-mail:
mhrp.gsi.oov.uk
11 b Device Category (GMDN):. 7
20. CAB/Notified Body no.:
0197- TUV Rheinland
Product Safety GmBH
13. GMDN No.: 36197
14. Trade name and make and model:
IMGHC-TX, IMGHC-MX, IMGHC-LS
15. Software version:
16. Serial no.:
17. Lot/batch no. All lots
18. Manufacturer: Poly Implant Prothese 19. Autho
rised rep:
Country: Franco
Country:
Full Address:
Full Address:
Contact:
337 avenue de Bruxelles
83507 La Seyne Sur Mer Cedex France
T e.1
Contact: tvlr couTy
Fax:
Tel: 04.94.10.98.10
E-mail:
Fax: 04.94.10.98.11
E-mail: [email protected]
21a. Device approval
status:
[X] CE mark
21b. Risk Class: III
22. Action taken:
[j None
[X] Field Safety Corrective
Action
[1 Safeguard Action
[] Other (specify)
Event Data
23a. Background information and reason fdrth
is report:
On Tuesday 30 March 2010 the French medica
l device regulatory authonty (AFSSAPS) inform
ed the MHRA that It
had suspended the marketing, distributiori, export
and the use of silicone gel filled breast implants manuf
PIP. AFFSAPS had carried out an inspection of the
actured by
PIP manufacturing plant and established that
breast implants
manufactured by PIP since 2001 had been filled
with a silicone gel with a composition different from
that approved.
The MHRA issued MDAI2O1 0/025 on 31 March
2010 advising UK clinicians not to implant these
devices.
In April 2010, AFSSAPS initiated testing of affecte
d implants to look atthe genotoxicity (potential
for cancer), chemical
toxicity and irritation to biological tissues, mecha
nical testing of the implant shell was carried
out. In addition to these
tests camed out by AFSSAPS the MHRA in July 2010,
commissioned tests to look atthe chemical toxicit
genotoxicity of the filler material. Results of the
UK tests have not shown any evidence of genotoxicity y and
toxicity of the flller material.
or chemical
-
23b. Is the investigation of the report complete? pYes
-
[x] No
24a. Conciusions:
Following consultation with indepencient clinical experts
in the UK, the MHRA issued a medical device alert on
4
October 2010 (MDN2O1O/078) advising UK clinicians to contac
t women implanted with PIP implants and to reassure
them that there is currently no evidence of any health risk associa
ted with the filler and there is no indication for any
routine action, in the form of explantation or ultrasound.
MDAI2O1O!078 can be found on the MHRA website (www.mhra.g
ov.uk)
24b. Have the manufacturer’s actions been made public in a Field
Safety
Notice? Yes JJ No [xl
24c. The originator of this NCAR will take the lead and co-ord
inate the investigation Yes [xJ No
25a. Recommendation to receivers of this report:
For your information.
25b. Device known to be in the market in (Distribution confirrnation from
manufacturer / authorized rep attached):
Worldwide
25c. Device also marketed as (trade name):
Report Distribution
26a. This report is being distnbuted to:
[X 1 The GHTF NCAR Secretariat for further distribution to all non
EEA GHTF FULL NCAR participants (AU CA JP NZ US)
[X 1 EEA states, EG, and Switzerland
[ 1 The following targeted NCAs:
The manufacturer / authorised rep:
26b The last GHTF-NCAR distnbuted by this NCA was: UK-20
10-09-031-091
182
10.2.e. (gehele document)
Ft,t1oderrri
B.V.
H S
Ei 5. A 0’ T 5’
0 H
.
0 S Si S
ro:rcn--r;
Inspectie voor de Gezondherdszorg
t. a v.
Postbus 90700
2509 LS DEN HNG
.
Breda, 7 oktober 2010
Betreft
Philoderm Aesthetics B.V. / Rofil Medical Nederland B.V.
Geachte
Betreffende uw inspectiebezoek op 23 september 2010 ten kantore van Philoderm
Aesthetics BV. te Breda, zend ik u zoals afgesproken de volgende bescheiden:
1. Nota’s Van Happen Containers d.d. 18september2009 resp. 12mei 2010 welke o.a.
betrekking hebben op de vernietiging van de PIP-implantaten in september 2009.
2. Lijst met afnemers van PlPprotheses gedurende de periode 2001 t!m 23 februari
2009 (faillissement Rofil Medical Nederland B.V.).
Ten aanzien van punt 2 merk ik nog het volgende op.
De lijsten over de periode 1 januari 2001 tlm 30 juni 2005 betreffende de afnemers en de
omzetbedragen m.b.t. de leverde PIP-protheses. De administratie werd gedurende die
periode verwerkt in een oud’ MS-DOS-programma waaruit wij tot op heden (nog) geen
aantallenoverzicht kunnen genereren.
In het vertrouwen u hiermee te hebben geïnformeerd, verblijf ik,
Met vriendelijke groet,
Philoderm Aethetics B.V.
Bijlaqen
Hc’’nj 16.8i7 :93
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Heusing 16
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-
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1
GROOTBOEK
-
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AKKOORD
-
Op al onze offerten, osereenkornsten, leverinen en d/ensten, zijn onze Alqsmene
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1O.2.e. (gehele document)
Inspectie voor de Gezondheidszorg
Ministerie van Volksgezondheid,
Welzijn en Sport
>
Retouradres Postbus 90460 2509 LL Den Haag
RoNI Medical International N.V.
Rofil Medical Nederland BV.
P/A Philoderm Aesthetics
T .a.v.
Heusing ib
4817 ZB BREDA
Geneesmiddelen En
Medische TechnoIoie
WHh. van Pruisenweg 52
Den Haag
Postbus 90460
2509 LL Den Haag
T 0703041500
F 070 304 15 70
www.igz.ni
Inlichtingen bij
Datum
12 oktober 2010
Onderwerp Vorderen informatie
flnç
Itflflmnrlt
Geacht
Tijdens het toezichtbezoek de Inspectie voor de Gezondheidszorg van 23
september 2010 heb ik u gevraagd om, uiterlijk een week na het bezoek, de
volgende informatie toe te sturen:
Een kopie van de factuur voor het afvoeren van de voorraden van Rofil
Medical Nederland B.V. na het faillissement;
Een overzicht van de aantallen implantaten zoals die vanaf 2001 per jaar,
per afnemer zijn geleverd in Nederland, in Europa buiten Nederland en in
de rest van de wereld.
-
Tot op heden heb ik niets van u ontvangen.
Met deze brief vorder ik de gevraagde informatie.
Ik wij u erop dat artikel 5:20 van de Algemene wet bestuursrecht luidt dat een
ieder verplicht is aan een toezichthouder binnen de door hem gestelde redelijke
termijn alle medewerking te verlenen die deze redelijkerwijs kan vorderen bij de
uitoefening van zijn bevoegdheden. De inspectie is bevoegd tot het opleggen van
een last onder bestuursdwang ter handhaving van deze verplichting.
Graag ontvang ik de gevraagde informatie uiterlijk op 20 oktober 2010.
Hoogachtend,
Pagina 1 van 1
207
1O.2.e. (gehele document)
Fhiloderrn®
Athtîz B.V.
Inspectie voor de Gezondheidszorg
tav.
Inspecteur
Postbus 90700
2509 LS DEN H,AG
::I
Ûu17/25 --4
r)
-
.
Breda. 14 oktober 2010
Betreft
Ref. Nr.:
Kopie brief d.d. 7 oktober 2010
In de bijlage vindt u een kopie van onze brief van 7 oktober ji.
Deze kopie wordt u gestuurd naar aanleiding van uw verzoek a
Tevens zal u een kopie toegestuurd worden via e-mail.
Vertrouwende u met deze informatie van dienst te zijn geweest,
Met vriendelijke groet,
Philoderm Aesthetics B,V,
Bijlage.
Heusfncl 16 4817 78 Breda The N hrand T +31 (076 3781311 F .31 0)76 5781312
nf
2’phdodermaPTrejcs.com
ww’r çhdodermaernEcs :om. KvK Br’-da 2006203? V47 N 801 40 894.8 01
E
Phioderm Ae eic: BV
30 8001 an 1 3433 ceferj
Inspectie voor de Gezondheidszorg
Ministerie van Volksgezondheid,
Welzijn en Sport
1O.2.e. (gehele document)
Postbus 90700
2509 LS
211
Den Haag
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Inspectie voor de Gezondheidszorg
Ministerie van Volksgezondheid,
Welzijn en Sport
>
Retouradres Postbus 90460 2509 LL Den Haag
Rofil Medical International N.V.
Rofil Medical Nederland BV.
P/A Philoderm Aesthetics
T .V.
Rtusiuy 16
4817 ZB BREDA
Geneesmiddelen En
F4edlsche Technologie
WiIh, van Pruisenweg 52
Den Haag
Postbus 90460
2509LL Den Haag
T 0703041500
F 070 304 15 70
www.igz.nI
Inlichtingen bij
12 oktober 2010
Datum
Onderwerp Vorderen informatie
Tijdens het toezichtbezoek de Inspectie voor de Gezondheidszorg van 23
september 2010 heb ik u gevraagd om, uiterlijk een week na het bezoek, de
volgende informatie toe te sturen:
Een kopie van de factuur voor het afvoeren van de voorraden van Rofil
Medical Nederland B.V. na het faillissement;
Een overzicht van de aantallen implantaten zoals die vanaf 2001 per jaar,
per afnemer zijn geleverd in Nederland, in Europa buiten Nederland en in
de rest van de wereld.
-
Tot op heden heb ik niets van u ontvangen.
Met deze brief vorder ik de gevraagde informatie.
Ik wij u erop dat artikel 5:20 van de Algemene wet bestuursrecht luidt dat een
ieder verplicht is aan een toezichthouder binnen cie door hem gestelde redelijke
termijn alle medewerking te verlenen die deze redelijkerwijs kan vorderen bij de
uitoefening van zijn bevoegdheden. De inspectie is bevoegd tot het opleggen van
een last onder bestuursdwang ter handhaving van deze verplichting.
Graag ontvang ik de gevraagde informatie uiterlijk op 20 oktober 2010.
Hoogachtend,
Inspecteur
Pagina 1 van 1
1O.2.e. (gehe’e document)
Van:
Aan:
Cc:
Datum:
Bijlagen:
Prioriteit:
222
IGZ
donderdag 4 november 2010 15:19:07
3582 001.odf
0844216-04 EC Desin Beflapel.pdf
0844213-03 (M2d
Hoog
Deai
As discussed over the phone, please find attached:
•
Certificates from Rofil Medical lmp)ants (OBL manufacturer)
•
Last updated certificates fron
(original manufacturer)
1 will remain at your disposal for any additional information you need.
Meilleures salutations / Best Regards
Medical Devices
SNCH, BP 23, L-5201 SANDWEILER
0ffice: 2a Kalschesbrèck L-1852 LUXEMBOURG
tel:
fax:
+
352
+
352 35 72 14
e-maîl:
-
244
:flL 1
Ii
GRAND-DUCHE DE LUXEMBOURG
1O.2.e. (gehele document)
sn€1i
Société Nationale de
Certification et d’Homologation
Notified Body
Organisme not ijlé Benannie Steile
-
N° 0499
EC Design Examination Certificate
Certificat d’examen CE de la conception
EG-A uslegungspri4fbescheinigung
according to annex II section 4 of directive 93/42/EEC
co,formémenr â l’annexe II section 4 de la directive 93/42/CEE
gemöss Anhang IlAbschnitt 4 der Richtlinie 93/42/EWG
Manufacturer:
ROFIL MEDICAL IMPLANTS Ltd.
Fabricani Hersieller:
-
Oroklini Huis 11 Ap. B32
Tinou 18
CY-7040 OROKLIM
—
Device Identification:
Identijication du dispositf- Produktidentflzierung:
Cohesive Silicone Gel-Filled Mammary
Prosth es is
M-Implants®
See SNCH-marked reference list dated 2010-03-18
for details 011 certified types.
Veuillez consulter la liste de reférences fnarquée SNCH ei da(ée
2010..03-18 pour ie délail des types certiflés.
Für Details zu zertflzierten Typen siehe SNCH-gekennzeichnere
Referenzliste vom 2010-03-18.
Registered Certificate No.:
104445 1-00
No. du cer4ficat Zertfikatsnr..’
-
The design of the device listed above is in conformity with the requirements of annex T of directive 93/42IEEC.
La conception du dispositfci-dessus est conforme aux e.xigences de 1 ‘annexe 1 de la directive 93/42/CEE.
Die Auslegung des obigen Produktes ist konform zu den Anforderungen aus Anhang Ider Richtlinie 93/42/EWG.
The certificate is valid until 2015-03-18.
Le Certijicat est vaiidejusqu ‘au 2015-03 -18.
Das Zertflkat ist gültig bis zum 2015-03-18.
Luxembourg, 2010-03-19
Société Nationale de Certification et d’Hornologation sâ r.l.
ii. mede Luxembourg
BP. 23
L-5201 Sandwef Ier 1 Luxembourg
(Int+352)
Fax (Jnt+352) 35 72 14-244
F2.! M24/ fl2 /2OO.o,’.IU
222.1
GRAND-DUCHE DE LUXEMBOURG
Sfl€Fi
Société Nationale de
Certification et d’Homologation
Notified Body
Organisme notiflé Benannte Steile
-
N° 0499
EC Certificate
Certijïcat CE /EG Zertifikat
Full Quality Assurance System Approval Certificate according to
Annex II of Medical Devices Directive (93/42/EEC)
Certificat de Système complet d’Assurance de Qualiié selon
Annexe II de le Directive relative aus Dispositifs Médicaux
(93/42/CEE)
Zertifikat des voilsilindigen Qua!ittitssicheruiigssystems nach
Anhang II der Richtilnie über Medizinprodukte
(93/42/EWG)
We certify that the Full Quality Assurance System of the company:
Nous cerrifions per la présente que le Systèine Coniplet d’Assurance de la Qua!ité de la société:
Wir bestëtigen, dafi das volisilindige Qualitiitssicherungssyste,n der Firma:
ROFIL MEDICAL IMPLANTS Ltd.
Oroklini Huis 11 Ap. B32
Tinon 18
CY-7040 OROKLINI
—
is in conformity with the following requirements:
est conforme aux exigeaces suiwantes:
denfolgenden A,fordenungen enispricht:
Annex II of Medical Devices Directive (93/42/EEC)
Annexe II dele Directive relative aux Dispositifs Médicaux (93/42/CEE)
Anhang II der Richtlinie über Medizinprodukte (93/42/EWG,)
The scope of the Full Quality System is detailed in annex, which is a constituent part of this certilicate.
Le domaine d’applieation du Système Complet dA ssurance de le Qualité est délaillé dans l’annexe qui est partie constituante dii présent
certificat.
Die Zweckbestim,nung des voilsiëndigen Qualitiitsskherungssystems ist im Anhang aufgeflihrt md ist Bestandteil des vorliegenden
Zertifikats.
Certificate
Certij7cat/Zeraflkat
No. 1044450-00
The certification is valid until 2015-03-18 and is subject to a yearly surveillance.
La erficatian est validejusqu’au 2015-03-18 ei est soumise â wie surveillance annuelle.
Die Zertifizierung ist gültig bis cum 2015-03-18 und unterliegt einerjdhrlichen Uberwachung.
Luxembourg, 2015-03-19
Société Nationale de Certification et d’Homologation s.â r.l.
1 , mede Luxembourg
BP. 23
L-5201 Sandweiler / hxembourg
(lrit+352)
Fax (Int+352) 35 72 14-244
F2-I.M2i4/ VI /20094e-s?
GRAND-DUCHE DE LUXEMBOURG
5fl€’
Société Nationale de
Certification et d’Homologation
Notified Body
Organisme no1fié Benannte Steile
-
N° 0499
Annex of Certificate No.
Annexe dit certijicat no. /Anhang zurn Zertifikal Nr.
1044450-00
ROFIL MEIMCAL IMPLANTS Ltd.
Scope: Design, manufacture and final inspection of
Domaine d ‘applicaiion: Conception, fabrication ei contrôle lima! de
Zweckbestimmung: Auslegung, Fertiguixg und Endkontro!!e von
Cohesive Silicone Gel-Filled Mammary Prosthesis
M-Implants®
See SNCH-marked reference list dated 2010-03-18 for details on certified types.
Veuillez consulter la liste de références marquée SNCH ei daiée du 2010-03-18 pour le détail des types certjflés.
FOr Details zu zer4flzierten Typen siehe SNcH-gekennzeichnete Referenzitste vom 2010-03-18.
This annex is only valid 1f attached to the certificate mentioned above.
La présenge annexe est seulement vatable en relation avec le certijicat mentionné ci-dessus.
Dieser Anhang kat nur Gültigkeit in Verbindung miii dein oben genannten Zertijikat.
Page Seite 1/2
-
Luxembourg, 2010-03-19
Société Nationale de Certification et d’Homologation s.â rJ.
11, mede Luxembourg
B.P. 23
L-5201 Sandweiler / Luxembourg
(Jnt+352)
Fax (Int+352) 35 72 14-244
F2.IM2, / VI /2009.08.27
imlcn1-,
Natural Profile
Rational Profile
lodel Name
Volume (cc) Width (mm) Profile (mm) Model Name
Volume (cc) Width (mm) Profile (mm)
MGHC-TX-N-125
125
94
28 IMGHC-TX-R-125
125
91
29
MGHC-TX-N-150
150
99
30 IMGHC-TX-R-150
150
96
33
MGHC-TX-N-175
175
104
31 IMGHC-TX-R-175
175
101
34
MGHC-X-N-200
200
32 IMGHC-TX-R-200
200
106
35
MGHC-TX-N-225
225
114
33 IMGHC-TX-R-225
225
III
36
MGHC-TX-N-250
250
119
35 IMGHC-TX-R-250
250
115
38
MGHC-TX-N-275
275
12.
36 IMGHC-TX-R-275
275
119
39
MGHC-TX-N-300
300
129
37 IMGHC-TX-R-300
300
122
40
IMGHC-TX-N-325
325
133
38 IMGHC-TX-R-325
325
125
41
MGHC-TX-N-350
350
136
38 IMGHC-TX-R-350
350
128
41
MGHC-TX-N-375
375
139
39 IMGHC-TX-R-375
375
131
42
MGHC-TX-N-400
400
142
39 IMGHC-TX.-R-400
400
134
43
MGHC-TX-N-425
425
144
40 MGHC-TX-R-425
425
138
44
MGHC-TX-N-450
450
146
40 MGHC-TX-R-450
450
140
44
MGHC-TX-N-475
475
149
41 IMGHC-TX-R-475
475
142
45
MGHC-TX-N-500
500
151
42 IMGHC-TX-R-500
500
144
47
MGHC-TX-N-525
525
153
43 IMGHC-TX-R-525
525
147
48
IMGHC-TX-N-550
550
15
43 IMGHC-TX-R.-550
550
150
48
L
Rofil I\AediczcI
Rofil MediccI
ImpIcnr, Ltd
Rational SmbotltStyleY
Natural Profile Smooth Style
Volume Width
Model name
Profile
(cc)
(mm)
(mm)
1 25
94
28
1 50
98
29
1 75
103
30
200
108
31
225
113
32
250
118
34
275
123
35
300
-128
36
125
325
IMGHC- LS -N
350
350
IMGHC-LS-N
375
132
37
IMGHC-LS -N
125
IMGHC- LS -N
150
IMGHC- LS -N
175
IMGHC-LS-N
200
IMGHC-LS-N
225
IMGHC- LS -N
250
IMGHC- LS -N
275
:9LS
300,
LS -N
IMGHC- LS -N
400
IMGHC-LS-N
IMGHC-LS-N
IMGHC-LS-N
IMGHC- LS -N
500
IMGHC-LS-N
IMGHC- LS -N
550
135
138
38
400
141
38
425
143
39
450
145
39
475
148
40
500
150
41
525
152
42
550
155
42
Volume Width
Model name
IMGHC-LS -R
125
IMGHC- LS -R
150
IMGHC- LS -R
175
IMGHC-LS-R
200
IMGHC-LS-R
225
IMGHC- LS -R
250
IMGHC- LS -R
275
IMGHC-LS-R
300
l
325
IMGHC- LS -R
350
IMGHC-LS-R
IMGHC- LS -R
400
IMGHC-LS-R
IMGHC-LS-R
IMGHC-LS-R
IMGHC- LS -R
500
IMGHC-LS-R
IMGHC- LS -R
550
Profile
(cc)
(mm)
(mm)
125
91
29
150
96
33
175
101
34
200
106
35
225
111
36
250
115
38
275
119
39
300
122
40
325
125
41
350
128
41
375
131
42
425
138
44
450
140
44
475
142
45
47
500
525
147
0
48
48
1 8 MARS
DCMIIOO3
P H
LOS OP H Y
Rofil Medicöl
ImpIc3nt Ltd
Medium Height Hight Profile
THE
Volume Width Profile Projection
Model name
IMREGTX-H
165
IMREGTX-H
195
IMREGTX-H
225
IMREGTX-H
260
IMREGTX-H
300
IMREGTX-H
345
IMREGTX-H
390
lEGT-H
40
lMREcrc -H
495
IMREGTX-H
555
(cc)
(mm)
(mm)
(mm)
165
90
85
46
195
95
89
48
225
100
94
51
260
105
99
53
300
110
103
56
345
115
108
58
390
120
113
60
440
125
118
62
122
65
127
67
49V.:
555
135
3EAUT’i’
PHiLOSOPHY
Ro191 Mediccil
ImpInt Ltd
High Profile Smooth Round Style
Volume Width
Model name
IMGHC-LS -H
125
IMGHC- LS -H
150
IMGHC- LS -H
175
IMGHC-LS-H
200
IMGHC- LS -H
225.
IMGHC- LS -H
250
IMGHC- LS -H
275
IMGHC- LS -H
300
lNiIC-LS-H
IMGHC- LS -H
350
IMGHC- LS -H
IMGHC- LS -H
400
IMGHC-LS-H
425
IMGHC- LS -H
450
IMGHC- [S -H
IMGHC-LS-H
500
IMGHC-LS-H
525
IMGHC-LS-H
550
Profile
(cc)
(mm)
(mm)
1 25
84
35
150
94
175
96
3
2 00
98
41
2 25
‘01
43
250
105
45
275
108
46
Ultra High ProfileSrnooth Round Style
Model name
IMGHC-LS -UH
120
IMGHC-. LS
UH 145
IMGHC- LS
UH 170
IMGHC-LSUH 195
IMGHC- LS
UH220
IMGHC- LS
UH 245
IMGHC- LS
UH 270
IMGHC- LS
UH 290
-
-
-
-
-
-
25
113
49
350
116
50
375
119
51
400
121
52
425
124
54
450
126
56
475
129
57
500
1 31
58
525
133
58
550
135
59
IMGHC- LS
UH 340
IMGHC- LS
UH 365
IMGHC- LS
UH 390
IMGHC-LSUH 415
IMGHC- LS
UH 440
IMGHC- LS
UH 460
IMGHC-LSUH 485
IMGHC-LSUH 510
IMGHC-LSUH 535
IMGHC-LS
UH_560
-
Volume Width
Profile
(cc)
(mm)
(mm)
120
75
41
1
85
45
170
87
46
195
89
47
220
91
48
245
94
49
270
96
51
290
99
52
315
102
55
340
104
56
390
109
58
415
111
59
440
113
60
460
115
61
485
117
62
510
119
63
535
121
64
0 S 0 P H
-
-
-
-
rw
1 8 MARS2 1’
—
‘
Pofil F\/ledic:cil
ImpIcnt, Ltd
Medium Hight Natural Profile
Volume
Model name
IMREGTX-N
IMREGTX-N
IMREGTX-.N
IMREGTX-N
MREGTX-N
IMREGTX-N
IMREGTX-N
lMRE3T(-N
IMREGTX-N
IMREGTX-N
(cc)
Medium Hight RationaIProfiIeL
Width Profile Projection
(mm)
(mm)
(mm)
180
105
99
38
215
110
103
39
245
115
108
40
280
120
113
42
315
125
118
44
355
130
122
46
395
135
127
47
440
.140
132
49
480
145
136
50
530
150
141
52
Model name
IMREGTX-R
IMREGTX-R
IMREGTX-R
IMREGTX-R
IMREGTX-R
IMREGTX-R
IMREGTX-R
IMREGTX-R
IMREGTX-R
IMREGTX-R
t:
DCMI1003
Volume Width
Profile
0 S 0 P H
Projection
(mm)
(cc)
(mm)
165
95
89
40
195
100
94
42
225
105
99
44
255
110
103
47
295
115
108
49
330
120-
113
51
375,
125
118
53
420
130
122
55
475
135
127
57
525
140
132
59
(mm)
Rofil F\Aedic:öI
ImpIcnts Ltd
UItraHighEPofiIeJTv
High Profile
Model name
IMGHC-TX-H
125
IMGHC-TX -H
150
IMGHC-TX -H
175
IMGHC-TX -H
200
IMGHC-TX -H
225
IMGHC-TX -H
250
IMGHC-TX -H
275
IMGHC-TX -H
300
IMGH-TX-H
-325
IMGHC-TX-H
350
IMGHC-TX -H
375
IMGHC-TX-H
400
IMGHC-TX-H
425
IMGHC-TX-H
450
IMGHC-TX -H
• IMGHC-TX -H
500
IMGHC-TX -H
IMGHC-TX -H
550
Volume Width
Profile
(cc)
(mm)
(mm)
2
15
84
35
36
150
175
97
38
200
99
40
225
102
44
250
10 6
46
275
109
47
f112
48
114
50
350
117
51
375
120
52
400
122
53
425
125
55
450
127
5
500
13 2
59
550
136
60
300:
25
..
-
Model name
IMGHC-TX-UH
120
IMGHC-TX -UH
145
IMGHC-TX -UH
170
IMGHC-TX -UH
195
IMGHC-TX -UH
220
IMGHC-TX -UH
245
IMGHC-TX -UH
270
IMGHC-TX -UH
290
IMGHc-Tx-UH
315
,
IMGHC-TX-UH
340
IMGHC-TX -UH
365
IMGHC-TX-UH
390
IMGHC-TX-UH
415
IMGHC-TX-UH
440
IMGHC-TX -UH
IMGHC-TX -UH
485
IMGHC-TX -UH
IMGHC-TX -UH
IMGHC-TX -UH
560
PHLOSOPHY
Volume Width
Profile
(cc)
(mm)
(mm)
120
70
41
14 5
86
46
17 0
88
47
95
90
48
220
92
49
2 5
95
50
2 0
97
52
100
53
315
103
56
3 0
105
57
365
108
58
390
110
59
415
112
60
4 0
114
61
485
118
63
124
66
5 5
560
222.2 GRAND-DUCHE DE LUXEMBOURG
1O.2.e. (gehele document)
shcJi
Société Nationale de
Certification et d’Homologation
Notified Body
Organisme not iflé Benannte Steile
-
N° 0499
EC Design Examina,tkn Certificate
Certijicat d’examen CE de la con ception
EG-A uslegungsprufl,escheinigung
according to annex II section 4 of directive 93/42/EEC
coformément â 1 ‘annexe II section 4 de la directive 93/42/C’EE
gemâss AnhangltAbschnitt 4 der Richtlinie 93/42/EWG
HANS BIOMED Corp.
Manufacturer:
Fabricant Herstelier:
-
8th SK bldg., 16-4, Sungsulga2-dong
Sungdong-gu.
Seoul, Korea
Device Identification:
Identij?cation du dispositf- Prodtidentij7zierung.
-
-
.
Silicone Gel-Filled Mammary
Impiant
BellaGel
See SNCH-marked reference List dated 2010-06-22
for details on certified types.
Veuillez consulter la liste de reXérences marquée SNCH et datée
201 0-06-22 pour !e détuil des types ceraflés.
FOr Details zu zertfizierren Typen siehe SNC’H-gekennzeichnete
Referenzilste vom 2010-06-22.
Registered Certificate No.:
0844216-04
No. du certflcat Zert!fikatsnr.:
-
The design of the device Listed above is in conformity with the requirements of annex 1 of directive 93/42IEEC.
La conception du dispositfci-dessus est co;!forme aux exigences de 1 ‘annexe 1 de la directive 93/42/CEE.
Die Auslegung des obigen Produktes 1sf konform zu den Anforderungen aus Anhang Ider Richilinie 93/42/EWG.
The certificate is valid until 2013-07-07.
Le Certificat est validejusqu ‘au 2013-07-07.
Das ertfikat 1sf gültig bis zum 2013-07-07.
Luxenibourg, 2010-07-15
Société Nationale de Certification et d’Homologation s.â r.I.
11, rue de Luxembourg
B.P. 23
L-5201 Sandweiler / Lwcembourg
(Int-t-352)
Fax (lnt+352) 3572 14-244
F2.LM24/Y3 /30J11-O7O3
222.3 GRAND-DUCHE DE LUXEMBOURG
10.2.e. (gehele document)
srIï
Société Nationale de
Certification et d’Homologation
Notified Body
Organisme izotifi Benannte Steile
-
N° 0499
EC Certlflcate
Certijicat CE /EG Zertijikat
Full Quality Assurance System Approval Certificate according to
Annex II of Medical Devices Directive (93142/EEC)
Certifi cel de S;steme complet d Assurance de Quahte selon
Annexe II dele Direciwe relative ar .D,sposiufs Medicaux
(93/424EE)
Zerlfikat des vol(standigen Qeahtcdsszelserungssyslems nacli
Anhang II der Richtimie uber Medsziisprodukte
(93/42/EWG)
We certify that the Full Quality Assurance System of the company
Neus certofions per lapresente qua Ie Systeine Complet d’Assurance dele Quciliie de la socide
Wir bestaligen, dafi das vollstdndlge Quallidtssicherungssysiem der Firma
HANS BIOMED Corp
8th SK bldg., 16-4, Suugsulga2-dong
Sungdong-gu,
Seoul, Korea
is in conformity with the following requirernents:
est confornie aux exigences suzvantes
denfolgenden Anforderungen entspnchi
Annex II of Medical Devices Directive (93/42/EEC)
Annexe II de la Directivè relative mix Dispositifs Médicaux (93/42/CEE)
Anhang II der Richtlinie über Medizitiprodukte (93/427E WG)
The scopeof the Full Quality System is detailed in annex, which is a constituent part of this certificate.
Le domaute d’appltcatoon da Sysieme Complet d’Assurance de le Qualite wI detaxile dans 1 annexe qut est partie constituante di, present
cer4flcaL
Die Zweckbesdmmung des vollstöndigen Qualii&sskherungssysteins ist un Anhang aufgeflihrt and ist Bestandteil des vorliegenden
Zer4flkats.
Certificate
Certijicat/Zer4fikat
No. 0844213-03
The certification is vahd until 2013-07-07 and is subject to a yearly surveillance.
La certification est validejusqu ‘au 2013-07-07 eC est soumise â une surveillance annuelle.
Dle Zerzifizlerung ist gflhiig bis zum 2013-07-07 und unterliegt einerjiïhrlichen Iiberwachung.
Luxembourg, 2010-07-15
Sociétb Nationale cle Certification et d’Homologation eb r.l.
BP. 23
11, rue de Luxembourg
L-5201 Sandweiler / Luxembourg
(lnt+352)
Fax (In 1+352) 3572 14-244
F2.lM214 / F2 /2010-07.02
GRAND-DU CIIE DE LUXEMBOURG
sn€h
Societe Nationale de
Certification et d’Homologation
Notified Body
Organisme not jfié Benaante Steile
-
N° 0499
Annex of Certificate No.
Anne.re dii certijïcat no. /Anlzang zuin Zertifikat Nr.
0844213-03
HANS BIOMED Corp.
Scope: Design, manufacture and imnal inspection of
Dom aine d’application: Conception,fabrication et contrôle final .1e
Zweckbestimmung: Auslegung, Fertiguug wad Endkontrolle von
L)evices
D,sjor:tfs
Frilulite
‘SNCH.markedrÉference Iists
,
-
.
-
.•
Listes ik flrencesmarquÉesS.%rîJ
SNH-geInnze1chneie Referenzksien
Silicone Gel—Filled Mammarv Iinplaiit
BeI1aCeP’
20100622
Hans Hair Transpianter and spare needies
20 10-06-22
This annex is only valid 1f attached to the certificate mentioned above.
La présenie annexe est seuleinent vakzble en relation avec le cerlfical menlionné ci-dessus.
DieserAnhaug hal nar Gültigkeit in Verbindung mii dein oben genannien Zer4flkal
Page Seite 1/1
-
Luxembourg, 20 10-07-15
Sociét Nationale de Certification et d’Homologation s.â r.L
B.P. 23
11, rue de Luxembourg
L-5201 Sandweiler / Luxembourg
(lnt+352)
F2.J.M2/y1 /20i9-0327
Fax (Int+352) 35 72 14-244
—
150
CSR-RP 125
CSR-RP 150
CSR-RP 175
(mm)
28
29
30
31
32
34
35
94
98
103
108
113
118
123
128
(cc)
125
150
175
200
225
250
275
300
325
CSR-NP 125
CSR-NP 150
CSR-NP 175
CSR-NP 200
CSRNP 225
CSR-NP 250
CSR-NP 275
CSR..NP 300
CSR-NP 325
CSR-NP 350
Volume diameter Height
Height
(mm)
155
CSR-HP 550
47
149
550
CSR-RP 550
42
550
59
135
550
CSR.-NP 550
58
133
525
CSR-HP 525
47
146
525
CSR-RP 525
525
CSR-NP 525
42
152
500
500
CSR-HP 500
46
143
500
CSR-RP 500
CSR-NP 500
58
131
475
CSR-HP 475
44
141
475
CSR-RP 475
41
150
40
148
475
57
129
CSR-NP 475
56
126
450
CSR-HP 450
43
139
450
145
450
CSR-NP 450
CSR-RP 450
39
143
425
CSR-NP 425
54
124
425
CSR-HP 425
43
137
425
CSR-RP 425
39
52
121
400
CSR-HP 400
42
133
400
CSR-RP 400
38
141
400
CSR-NP 400
51
119
375
CSR-HP 375
41
130
375
CSR-RP 375
38
138
375
CSR-NP 375
50
116
350
CSR-HP 350
40
127
350
CSR-RP 350
37
135
350
49
113
325
CSR-HP 325
40
124
325
CSR-RP 325
37
132
47
111
300
CSR-HP 300
39
121
300
CSR-RP 300
36
560
22 iUH 2tfli3
535
CSR-UH 560
510
485
460
440
415
390
365
340
315
290
CSR-UH 535
CSR-UH 510
CSR-UH 485
CSRUH 460
CSR-UH 440
CSR-UH 415
CSR-UH 390
CSR-UH 365
CSR-UH 340
CSR-UH 315
CSR-UH 290
63
64
65
121
123
62
61
60
59
58
57
56
55
52
119
117
115
113
111
109
107
104
102
99
51
46
108
275
CSR-HP 275
270
CSR-UH 270
38
118
275
CSR-RP 275
49
96
245
CSR-UH 245
45
105
250
CSR-HP 250
37
114
250
CSR-RP 250
48
94
43
101
CSR-HP 225
225
35
110
225
CSR-RP 225
47
89
91
46
87
195
45
85
220
41
CSR-UH 220
(mmi)
75
1-Icight
(mm)
diameter
CSR-UH 195
41
200
CSR-H1’ 200
98
34
105
200
CSR-RP 200
39
175
CSR-HP 175
96
33
100
170
175
145
CSR-UH 170
94
150
CSR-HP 150
CSR-UH 145
32
95
125
CSR-HP 125
(cc)
Volume
37
29
91
125
Cat. No
Ultra High Profile
120
35
84
diameter Height
(min)
(cc)
Volume
(ma)
Cat. No
High Profile
/ Model
Medical Dewce Development Team
HANSBIOMED Product Standard
CSR-UH 120
(mm)
(im)
(cc)
Cat. No
diameter
Cat. No
Rationizi Profile
?‘
Silicone Gel-fihled Mammary Implant
Volume
Natura! Profik
Attachment 1
47
48
50
51
102
106
109
112
114
117
120
225
250
275
300
325
350
375
400
CTR-HP 225
CTR-HP 250
CTR-HP 275
CTR-HP 300
CTR-HP 325
CTR-HP 350
CTR-J-IP 375
CTR-HP 400
CTR-HP 425
36
38
39
40
41
41
42
43
44
44
111
115
119
122
125
128
131
134
138
140
142
144
225
250
275
300
325
350
375
400
425
450
475
500
525
550
CTR-RP 225
CTR-RP 250
CTR-RP 275
CTR.-RP 300
CTR-RP 325
CTR-RP 350
CTR-RP 375
CTR-RP 400
CTR-kP 425
CTR-RP 450
CTR-RP 475
CTR-RP 500
CTR-RP 525
CTR-RP 550
33
35
36
37
38
38
39
39
40
40
41
42
43
43
114
119
124
129
133
136
139
142
144
146
149
151
153
156
225
250
275
300
325
350
375
400
425
450
475
500
525
550
CTR-NP 225
CTRNP 250
CTR-NP 275
CTR-NP 300
CTR-NP 325
CTR-NP 350
CTR-NP 375
CTR-NP 400
CTR-NP 425
CTR-NP 450
CTR-NP 475
CTR-NP 500
CTR-NP 525
CTR-NP 550
535
560
CTR-UH 485
CTR-UH 510
CTR-UH 535
CTR-UH 560
58
59
59
60
130
132
134
136
475
500
525
550
CTR-HP 475
CTR-HP 500
CTR-1-IP 525
CTR-HP 550
45
47
48
48
147
150
510
485
22 JIJIN 2010
CTR-UTI 460
460
440
57
127
450
CTR-HP 450
CTR-UH 440
55
125
415
390
425
CTR-UH 415
365
340
315
290
53
CTR-UH 390
CTR-UH 365
CTR-UH 340
CTR-UH 315
CTR-IJ.H 290
270
245
CTR-UH 245
CTRUH 270
195
220
CTR-UH 220
122
46
44
40
CTR-UH 195
90
99
200
CTR-HP 200
35
106
200
C1’R-RP 200
32
109
200
CTR-NP 200
38
97
175
CTR-HP 175
34
101
175
CTR.RP 175
31
170
CTR-UN 170
100
66
65
122
124
64
63
62
61
60
59
58
57
56
53
120
118
116
114
112
110
108
105
103
52
50
95
97
49
48
47
46
41
(mi)
1-1cigEt
92
86
88
145
CTR-UH 145
75
(iie)
diameter
36
104
CTR-NP 175
95
175
150
CTR-HP 150
33
150
CTR-NP 150
j
(cc)
35
96
125
CTR-NP 125
1
Volume
120
Cat. No
Ultra High Prafile
Medica( Device Dei’eloprnen( Team
HANSBIOMED Product Standard
CTR-UH 120
(iie)
150
84
(ee)
CTR-RP 150
125
CTR-HP 125
29
91
(cc)
Volume diameter Height
30
(cc)
Cat. No
(iie)
Height
(Die)
Volume diameter
99
(»nu)
Cat. No
125
(ei)
Height
CTR-RP 125
1
11 diameter
High Profile
28
(cc)
Volume
Rationa! Profile
/ Model
94
Cat. No
Natura! Profile
Attachment 1
115
120
245
280
315
CAM—NP 280
CAM—NP 315
CAM—NP 355
2
127
135
555
CAM—HP 555
59
132
140
525
CAM—RP 525
52
141
150
530
CAM—NP 530
57
127
135
475
CAM—RP 475
50
136
145
480
130
495
CAM—HP 495
CAM—NP 480
122
125
440
CAM—HP 440
55
122
130
420
CAM—F1P 420
49
132
140
440
CAM—NP 440
120
390
CAM—HP 390
53
CAM—RP 375
47
127
135
395
118
125
375
CAM-NP 395
51
113
120
330
CAM—RP 330
46
122
130
355
56
118
113
67
65
62
60
58
103
345
CAM-HP 345
108
110
115
300
CAM—HP 300
49
108
115
295
CAM—RP 295
44
118
125
53
99
105
260
CAM—HP 260
47
103
110
255
CAM—RP 255
42
113
51
94
100
225
CAM—HP 225
44
99
105
225
CAM—RP 225
40
108
48
89
195
CAM—RP 195
39
CAM—HP 195
42
94
100
195
CAM—NP 245
103
110
215
46
85
165
95
(mat)
90
j
Height projection
165
(cc)
Volume] Width
(mat)
CAM—RP 165
(mi)
(mi)
(cc)
(mi)
CAM—l-IP 165
Cat. No
40
Heigh( projection
89
Width
95
CAM—NP 215
38
99
105
180
Volume
Medical Devica Development Team
HANSBIOMED Product Standard
Medium Height High Projile
(lam)
Cat. No
Medium Height Rational Profile
e / Model
(mi)
CAM—NP 180
projection
(arn)
Width
(lam)
Volume
(cc)
Cat. No
Hdght
Medium Heiglit Natura! Profite
Attachment 1
Attachment 1
53
55
56
58
59
60
61
63
64
65
68
108
111
114
117
119
122
124
127
130
132
136
275
300
325
350
375
400
425
450
475
500
550
CTC—UH 275
CTC—UH 300
CTC—UH 325
CTC—IJH 350
CTC—UH 375
CTC—UH 400
CTC—UH 425
CTC—UH 450
CTC—UH 475
CTC—UH 500
CTC—UH 550
53
54
56
57
58
59
60
61
62
63
66
108
111
114
1 17
119
121
124
127
129
131
135
275
300
325
350
375
400
425
450
475
500
550
CSC—UH 300
CSC—UF1 325
CSC—UH 350
CSC—UH 375
CSC—UH 400
CSC—UH 425
CSC—UH 450
CSC—UH 475
CSC—UH 500
CSC—IJH 550
CSC—UH 275
52
CTC—UH 250
51
105
250
CSC—UH 250
105
50
101
101
225
CSC—IJH 225
250
48
97
200
CSC—UH 200
225
Heighi
CTC—UH 225
Diameter
50
(cc)
Volume
48
Cat. No
200
(iai)
CTC—UH 200
Height
(nai)
(ria)
Diameter
(cc)
97
Volume
Conical Sisaped Ultra High Profile
pe / Model
(ei)
Cat. No
Conical Shaped Ultra High Profit
/ Model
22itllN21ü
(
A’fedical Device Development Team
HANSBIOMED Product Standard
Hans Biomed
Submission Dossier to SNCH for CE-Marking Conformity
For Hans Hair Transpianter
HAN
Bic,md/
HANS BIOMED CORPORATION
P.O.BOX
H.O: 8 SK bldg., 16-4, Sungsulga2-clong, Sungdong-gu, Seoul, Korea
M.O : 461-37, Jeonmin-dong, Yuseong-gu, Daejeon, Korea
Product size of general type and clip type hair transpianters
Hans flair Transpianter
HT-08
General
type
HT-lO
HT-AO8
Clip
type
HT-A1O
Needie O.D(mm)
O.8flini
Body Length(mm)
104.Omm
1.Omm
O.Xmm
1.Omm
104.Omm
104.Omm
104.Omm
Product size of general type and clip type
spare needies
Needie O.D(mm)
Spare Needie
O.8mm
HN-08
General
type
1.Omm
1-IN-lO
O.8mm
HN-A08
Clip
type
1.Omm
J--AlO
239
Phîloderm
10.2.e. (gehele document)
AehetIc B,V.
S 4
H
Inspectie voor de Gezondheidszorg
ta.v
Post •IJ1IfluI
2509 LS DEN HAAG
-
U
S H 1 L 0 S
5
;ie.:r9
..
9 Ni
Breda, 18 november 2010
Betreft :
__.;
Philoderm Aesthetics B.V.
Geachte
In goede orde ontving ik uw schrijven d.d. 11 nove
verzoek om een afschrift van de overeenkomst met
Regulatory Affairs officer.
‘‘n onder meer het
k’an Biotop Medical als
Terzake bericht ik u als volgt.
Het is mij niet duidelijk op basis van welke wettelijke bepalingen Philoderm Aesthetcs BV.
gehouden zou zijn u inzage te geven in met derden aangegane overeenkomsten van
diensten.
Te meer nu Philoderm Aesthetics BV. geen fabrikant van medische hulpmiddelen is.
Volledigheidshalve merk ik op dat het bovenstaande nadrukkelijk niet dient te worden
beschouwd als een weigering mee te werken aan uw verzoek maar dient te worden gezien
ter bewaking van onze juridische positie (ook jegens Biotop Medical).
In het vertrouwen u hiermee te hebben geïnformeerd en van u te mogen vernemen, verblijf
ik.
Met vriendelijke groet,
Philoderm Aethetics BV.
Heung 16
S
‘
4817 B Breca .Tre Nerrirland; T 3i 076 5781311 •F 31 (075 5781312
www ;il iij
aeht:sccm qK Breia 20062037 VAJ NL 5011.40.394.5 0
Pho4erm Aestrc5 3%
so
9001 ara 13485 (:p(t0e4
S II
283
10.2.e. (gehele document)
>
Inspectie voor de Gezondheidszorg
Ministerie van Volksgezondheid,
Welzijn en Sport
Retouradres Postbus 90700 2509 LS Den Haag
Philoclerm Aesthetics BV
T. a .v.
Heusing 16
4817 ZB BREDA
Datum
15 februari 2011
Onderwerp Verzoek om doorgeleiding te verzorgen
Werkgebied Zuidwest
WiIh. van Pruisenweg 52
Den Haag
Postbus 90700
2509 LS Den Haag
T 070 304 15 00
F 070 304 15 70
www.Igz,nI
Bij lagen
Geachte
Bijgevoegd ontvangt u een afschrift van een brief die ik aan
heb gestuurd. Ik verzoek ervoor zorg te dragen dat hij dit stuk ontvangt. Mochten
er redenen zijn waarom u niet in de mogelijkheid verkeert om hiervoor zorg te
dragen, dan verzoek ik u mij dit per direct te laten weten.
Bijlage: brief Rofil Medical Aesthetics, Cyprus
Pagina 1 van 1
284.
1O.2.e. (gehele document)
Health Care Inspectorate
Ministry ofHeafth, Welfare and Sport
>
Postal address P0. Box 90700 2509 LS The Hague The Netherlands
Reglon Southwest
7040 OROKLINI
Cyprus
WiIh. van Pruisenweg 52
The Hague
F.0. Box 90700
2509 LS The Hague
The Netherlands
T +31 70 304 15 00
F +31 70 304 15 70
www.Igz,nI
Our reference
Date
Subject
February 15, 2011
Bevestiging calculated risk
Geachte
Bij de afrondende rapportage over de recali van de implantaten van PIP / M
Implants heb ik nog een vraag voor u. U heeft aangegeven dat de meldingen van
lekkage bij u binnen de algemeen geaccepteerde grenzen bleven. De Franse
toezichthouder (Afssaps) noemde een percentage van ‘ongeveer 1%’ als wat in de
branche normaal is.
BioTop Medical in Leiden heeft ons
gezegd dat uit literatuuronderzoek een faalkans ‘kleiner dan 1%’ zou blijken.
Kunt u bevestigen dat Rofil uitgegaan is van het zelfde percentage?
Ik zie uw schriftelijke reactie graag binnen twee weken na dagtekening tegemoet.
!I1
liI
Page 1 of 1
285
1O.2.e. (gehele document)
FhiIoc.: erm
AEsthetIt B.V.
F_
5.-ï5
P01.Çj5ç.’7
Inspectie voor de Gezondheidszorg
ta.ij.
Poswus utuu
2509 LS DEN HAAG
Breda, 17 februari 2011
Betreft
Philoderm Aesthetics B.V.
Geachte
In goede orde ontving ik via
w schrijven d.d. 15 februari 2011.
Hierbij bevestia ik dat Rofil is uitgegaan van het zelfde percentage zoals aangegeven door
In het vertrouwen u hiermee te hebben geïnformeerd, verblijf ik,
Hoogachtend
Philoderm Aesti
1
Hunq 16’.487 28 Brda rhe 1
e4dsT 3i 016 5781311
31 076 58i32
E nfo’4 Dhlcdirrraesthe0cs corn
.wjw. oderrndetheto;s.corn KK Bcda 20062037 VAT NL 801 1 40.804 8.01
Phiioderrn AstherVs BV s 50 9001 arol 13485 c-rfieo
-
--
287
1O.2.e. (gehele document)
Inspectie voor de Gezondheidszorg
Ministerie van Volksgezondheid,
Welzijn en Sport
>
Retouradres Postbus 90460 2509 LL Den Haag
Geneesmiddelen En
Medische Technologie
Rofil Medical Nederland BV
T.a.v.
pia Philoderm Aesthetics BV
Heusing 16
4817ZB BREDA
Wilh. van Pruisenweg 52
Den Haag
Postbus 90460
2509 LL Den Haag
T 070 304 15 00
F 070 304 15 70
www.igz.nI
Ons kenmerk
Datum
24 februari 2011
Onderwerp Omzetcijfers M-rmplants in Nederland
Tijdens het inspectiebezoek van 22 februari 2011 heeft u mij de gemiddelde
verkoopsprijs van uw implantantaten over de jaren gegeven,
had
mij eerder omzetcijfers per jaar gegeven, zodat ik nu een onderbouwde schatting
kan maken van de verkochte aantallen. Hieronder staan de resultaten hiervan.
jaar
2001
2002
2003
2004
2005
Totaal
bmzet Euro
-
Gem. prijs
Schatting aantal
verkocht
652
254
206
253
340
10.1.c.
1705
Pagina 1 van 3
De gegevens over 2006-2009 die
gedetailleerd:
mij gegeven heeft zijn meer
Datum
-
-
-
2006
2
2
33
-7
2007
4
40
4
44
2
6
191
7
74
51
38
10
2
137
251
2
12
1
857
Totalen
-
2008
2009
-26
24 februari 2011
1O.1.c.
46
-2
-4
-15
4
33
8
28
4
18
8
4
6
2
8
2
94
83
-2
Conclusie van de inspectie is daarmee dat bovenop de schatting van 1705
implantaten die verkocht zijn in de periode van 2001 2005, er nog eens 1032
middelen in de periode van 2006-2009 bij komen. Hierbij kom ik in totaal uit op
2737 verkochte implantaten in Nederland. Ik verzoek u aan te geven in hoeverre
dit een juiste schatting is. Mocht u uitkomen op andere cijfers, dan verneem ik dat
graag inclusief onderbouwing binnen twee weken van u.
—
—
—
Ik verzoek u verder mij afschriften te sturen van de analyses die u heeft gemaakt
van uw viglilantiegegevens en de gegevens uit de post market surveillance
geordend per jaar over de periode 2001 tot en met 2008. Een fabrikant van een
medisch hulpmiddel van klasse III is verplicht deze gegevens bij te houden. In het
kader van uw kwaliteitssysteem zou op grond van deze analyses een advies aan
het management moeten zijn opgesteld. Ik vraag u ook deze adviezen geordend
per jaar aan mij te doen toekomen. Ik verzoek u mij deze gegevens schriftelijk
Pagina 2 van 3
binnen twee weken naar mij op te sturen. Eventueel kunnen afschriften
volstaan.
Wellicht ten overvloede wijs ik u erop dat de inspectie op basis van de artikelen
5.16 en 5.17 van de Algemene wet bestuursrecht bevoegd is deze informatie te
vorderen.
ri]TIiI.i[.N.
Datum
24 rebruari 2011
Pagina 3 van 3
289
Philoderm®
10.2.e. (gehele document)
AebthetIc B.V.
S
.
0 S 0
Inspectie voor de Gezondheidszorg
tav.
Postbus 90700
2509 LS DEN HAAG
-
2Ol
—i
Breda, 3 maart 2011
Betreft :
Rofil Medical Nederland B.V.
Geachtel
In goede orde ontving ik via
w brieven d.d. 23 resp. 24 februari 2011.
Dienaangaande bericht ik u als volgt.
1. Schatting verkochte aantallen borstprothese
s 2001 tlm 2005
Ik kan uw schatting volgen.nu ik niet over andere gege
vens dan u beschik.
2. Vigilantiegegevens etc. over de periode 2001
tlm 2008
De vigilantiegegevens, managementreview en
post market surveillance over de periode
2001 tlm 2008 heb ik verzameld.
Deze (omvangrijke) documentatie staat voor u gere
ed om afgehaald te worden ten kantore
van Philoderm Aesthetics B.V.
3. Verkochte aantal borstprotheses per klini
ek over de periode 2001 t!m 2005
Ik kan uit de administratieve systemen geen ander over
zicht produceren dan ik u in eerdere
instantie heb verschaft.
De specifieke aantallen zouden eventueel door een
fysieke analyse van de )omvangrijke)
administratie van Rofil Medical Nederland BV eventueel
kunnen worden gereproduceerd.
Ik beschik niet over de administratieve mankracht e.e.a
. uit te voeren. Wellicht dat de curator
van Rofil Medical Nederland B.V. hier tijd en kosten
aan wil spenderen nu de administratie
van Rofil Medical Nederland B.V. onder zijn verantwo
ordelijkheid valt.
Heiisng 16 4817 ZB Breda -The Netherlands
‘T +31 (0)76 5781311 -F +31 (0)76 5781312
E [email protected]
www.philodermaesthetics.com .KvIK Breda 200620
37 —VAT NL 8011 40.894,B 01
PhIoderrn Aesthetics BV is ISO 9001 and 13485
certified
PhIIoderm
AesthetIc B.V.
In het vertrouwen u hiermee te hebben gefnformeerd, verblijf ik,
Heusing 16.4817 ZBBreda.TheNetherlands-T+31 (0)765781311 ‘F +31 (0)76 5781312
E [email protected] • wwwphiodermaestheticscom • KvK Breda 20062037 -VAT NL 8011 .40.894.B.01
Ph,ioderm Aesthetics BV is SO 9001 and 13485 certified
291
PhiIode’rm®
10.2.e. (gehele document)
A9sthetics -B V
1—1
3 L ) Li
Ii II
Inspectie voor de Gezondheidszorg
Tav.
Postbus 90460
2509 LL Den Haag
Breda, 14maart2011
Betreft: Omzetcijfers M-Implants Nederland
De in de brief van 24 februari 2011 gevraagde informatie is verzameld in 1 doos met
als inhoud:
Vigilantiegegevens:
Post Market Surveillance:
Management Review:
4 mappen
3 mappen
2 mappen
Totaal:
9 mappen
Door IGZ in ontvangst genomen d.d.: 14 maart 2011
Handtekening voor ontvangst:
Naam:
Heusing 16
4817 ZO Breda
The Netherlands T +31 (0)76 5781311
F +31 (0)76 5781312
[email protected] 1 www.philodermaestheticscom KvK Breda 20062037
Philoderm Aesthetcs BV is 150 9001 and 13485 certified
VAT NL 8011.40,894.0 01
303
919
) J J
1O.2.e. (gehele document)
cifriurn
medisch centrumparksiad
inspectie voor de Gezondheidszorg
Medische Technologie
Postbus 90460
2509 LL DEN HAAG
datum: 24 maart 2011
ons kenmerk:
kenmerk:
senior inspecteur
kopie:
Betreft: meldingen M-implants van Rofil
Geachte
In uw brief van 1 0 maart inzake meldingen M-lmplants van Rofil hebben wij in goede orde
ontvangen.
Graag ontvangt u nog een overzicht van alle meldingen van falende implantaten die wij aan
Rofil hebben gedaan. Het vergt enige tijd om alle informatie uit de dossiers boven water te
krijgen. Het is dan ook niet mogelijk om dit binnen 3 weken aan te leveren.
Hopende u hiermee voor dit moment voldoende te hebben geïnformeerd.
z1
t,
/ lid Raad van Bestuur
304
a,k)
CAAJ
10.2.e. (gehele document)
11—
atrr
r
’
1
j J
medisch centrum parkstad
Inspectie voor de Gezondheidszorg
Inspecteur
Postbus 90460
2509 LL Den Haag
Raad van Bestuur
tel. (045)
fax (045) 5767474
e-mailadres: [email protected]
WÎlt u s.v.p. bij uw reactie
ons kenmerk vermelden.
datum: 14 april 2011
bijlage:
kopie:
ons kenmerk:
uw kenmerk:
1
Betreft: reactie inzake Rofil borstprothesen
Geachte
Naar aanleiding van uw verzoek om een overzicht van alle meldingen aan ROFIL van falende
implantaten die in het verleden in Atrium Medisch Centrum Parkstad werden geïmplanteerd
kan ik u als volgt informeren.
Van alle implantaten, die in het verleden vanwege lekkage zijn geëxplanteerd, is melding
gedaan bij ROFIL en werd de lekkende prothese conform afspraak opgestuurd. Als antwoord
ontvingen wij steeds bericht dat geconstateerd was dat de prothese stuk was, maar er werd
nooit een oorzaak in het materiaal geconstateerd. Als tegemoetkoming werden de prothesen
vergoed. Hierover bestaat geen correspondentie.
In 2008 werd het bericht van ROFIL vergezeld van een analyserapport waarvan ik de
voorhanden zijnde rapporten volledigheidshalve bijsluit.
De plastische chirurgie heeft mij laten weten dat alle patiënten met implantaten van ROFIL,
die geen gevolg hebben gegeven aan de controleafspraak, zijn aangeschreven en uitgenodigd
om contact op te nemen. Het aantal personen dat gereageerd heeft op de oproep is meer
//
dan 50%.
Met vriendelijke groet,
Rofil Medical Nederland BV.
4847 AL Teteriogen
Willem Aleariderpleiri 11
F *31 (0)76 5315660
T -31 (0)76 5315670
1 www rol ii corn
info@rcfil corn
VAT NL 800361271301
KvK Breda 20062072
The Netherlands
304.1
Atrium Medisch Centrum Heerlen
T.a .v. Afdeling Plastische Chirurgie
Henri Dunantstraat 5
6401 CX HEERLEN
Breda, 20 november 2008
Onze ref.:I
Betreft:i
Hierbij sturen wij u het analyserapport betreffende de klacht van twee
en
borstimplantaten met lotnummers
Het analyserapport wijst uit dat uw klacht gegrond is.
Vriendelijk verzoek om binnen 14 dagen contact op te nemen met
onze Customer Service om vervanging te bespreken.
van
Mocht u vragen hebben betreffende deze informatie, aarzelt u dan niet om contact op
te nemen met
Ervan uitgaande u hiermee voldoende te hebben geïnformeerd, verblijven wij,
Met vriendelijke groeten,
Bijlagen
THE
BEAUTY
PHILOSOPHY
SQIII4 FOR 803 C
IPIP
ANALYSIS REPORT
Implementation date
29oct2008
POLY MPLANTS PTtOTHEtES
Page 2 of 2
304.1.1
DATA COLLECTION
PIP file Nt
Analysis date: 27/10/2008
Reason for return: Explantation
Implantation date: 16/08/2005
Explantation date: 12/09/2008
lmpantation time: 3 years
Distributor:
Hospital: Artrium medisch centrum
Surgeor
Patient:
Product identification: IMGHC-TX
Batch 1 serial number: 45204-00 1
Volume: 245 cc
INCIDENT REPORTING
The prosthesis was explanted some 3 years after the implantation because of rupture.
SHELL SCHEMA AND PHOTO
PATCH SIDE
UPPER LEFT
QUADRANT
UPPER RIGHT
QUADRÂNT
—
LOWER LEFT
QUADRANT
LOWER RIGHT
QUADRANT
ANALYSIS RESULT
We found that the explant to be grossfy tom. The envelope thickness was checked throughout and no
value was found to be outside the manufacturing specification(1). All values being within the
parameters set for this type of implant.
We microscopically examined all along the Iengths of the tears but we could not identify the origin of
the rupture nor any evidence of surgical damage.
(1) Thickness of the shell:
For a texturedimplantbetween 0,57 mm and 0,95 mm
For a smooth implant between 0,40 mm and 0,63 mm
Analyst(s):
_
fj
ANALYSIS REPORT
PIJ?
IOLY IMPLANÎS PROTHE5ES
of 2
DATA COLLECTION
PIPfile N
Analysis date: 27/10/2008
Reason for return: Explantation
Implantation date: 16/08/2005
Explantation date: 12/09/2008
Implantation time: 3 years
Distributo,
Hospital: Artrium medisch centrum
Surgeon:
patient:r
Product identification: MGHC-TX
Batch 1 serial number: 31004-0 17
Volume: 245 cc
INCIDENT REPORTING
The prosthesis was explanted some 3 years after the implantation because of rupture.
SHELL SCHEMA AND PHOTO
PATCH SIDE
UPPER RIGHT
QUADRANT
UPPER LEFT
QUADRANT
—
.
—
—
LOWER LEFT
QUADRANT
LOWER RIGHT
QUADRANT
ANALYSIS RESULT
later
Manipulation of a breast implant at the time of insertion could predispose the device to fail at a
of
the
status
and
explantation
during
compromised
be
could
date, however the integrity of an implant
result.
as
a
classified
mistakenly
be
could
intact
implant
an
this
Although from the literature most implants seem to rupture eventualfy, It is most unfortunate
particular implant did not last as long as anticipated.
the
We found a substantialfy “U” shaped tear in the lower left quadrant 1-cm from the equator of
the
outside
to
be
found
was
value
no
and
throughout
checked
explant. The envefope thickness was
>. All vafues being within the parameters set for this type of implant.
11
manufacturing specification
Using a microscope, we looked carefufly all along the tear walis to identify the point of origin. Despite
this it was not possible to clearly determine why this implant ruptured.
(1) Thickness of the shell:
For a textured implant between 0,57 mm and 0,95 mm
For a smooth implant between 0,40 mm and 0,63 mm
Analyst(s):
Rofil Medical Nederland BV.
Willem Alexanderplein 11
4847 AL Teteringen
T +31 (0)76 531 5670
F -31 (0)76 531 5660
[email protected]
wwwrofilcom
KvK Breda 20062072
The Netherlands
VAT NL 800361271801
Atrium Medisch Centrum Heerlen
” ‘-“‘hirurgie
1
T.a.v A
6401 CX HEERLEN
Breda, 20 november 2008
Onze ref.
Betreft:
Geachte
Hierbij sturen wij u het analyserap
borstimplantaten met lotnummers
rf h
nde de klacht van twee
Het analyserapport wijst uit dat uw klacht gegrond is.
Vriendelijk verzoek om binnen 14 dagen contact op te nemen me.
onze Customer Service om vervanging te bespreken.
.
Mocht u vragen hebben betreffende deze informatie, aarzelt u dan niet om contact op
te nemen met
Ervan uitgaande u hiermee voldoende te hebben geïnformeerd, verblijven wij,
Met vriendelijke groeten,
Rofil Medical Nederland B.V.
Bijlagen
HE
BEAUTY
PHILOSOPHY
304.2
DATA COLLECTION
PIP file N
Analysis date: 27/10/2008
Reason for return: Explantation
Implantation date: 09/08/2005
Explantation date: 12/09/2008
Implaritation time: 3 years
Distributor:
Hospital: Not communicated
Surgeon:
Patient:
[
Product identification: IMGHC-TX
Batch 1 serial number: 19604-002
Volume: 285 cc
INCIDENT REPORTING
This expiant is the contralateral implantofunitnumber 19604-017.
SHELL SCHEMA AND PHOTO
PATCH SIDE
ANALYSIS RESULT
cut
A 3-mm cut was found in the ower left quadrant, 1 5-mm from the equator of the explant. A 8-mm
envelope
The
explant.
the
of
equator
the
from
1-cm
quadrant,
right
upper
was also found in the
thickness was checked throughout and no value was found to be outside the manufacturing
. All values being within the parameters set for this type of implant,
1
specificatiori
SQ1/14FORT
11 PJ1?
ANALYSIS REPORT
Implementation date
29oct2008
tOLY JMPLANTS
Page lof 4
DATA COLLECTION
PIP file Nt
Analysis date: 27/10/2008
Reason for return: Explantation
Implantation date: 09/08/2005
Explantation date: 12/09/2008
Implantatiori time: 3 years
Distributor
Hospital: Not communicated
Surgeon:
Patient:
Product identification: IMGHC-TX
Batch / serial number: 19604-017
Volume: 285 cc
INCIDENT REPORTING
The prosthesis was explanted some 3 years after the implantation because of rupture.
SHELL SCHEMA AND PHOTO
PATCH SIDE
UPPER LEFT
QUADRANT
UPPER RIGHT
QUADRANT
studied under
the microscope
LOWER LEFT
QUADRANT
Microscopy x63
QUADRANT
We microscopicaty examined all along the lengths of the tears but we could not identify the origin of
the rupture nor any evidence of surgical damage.
(1) Thickness of the shell:
For a textured implant between 0,57 mm and 0,95 mm
For a smooth implant between 0,40 mm and 0,63 mm
Analyst(s):
Rofil Medical Nederland B.V.
4847 AL Teeringen
W1(ern Alexanderplen 11
F -31 (076 5315660
T .31 (0)76 5315670
1 www rofil corn
E nfo@rofiLcom
VAT NL 800361271B01
KvK Breda 20062072
The Netherlands
Atrium Medisch Centrum Heerlen
T.a.v. Afdeling Plastische Chirurgie
Henri Dunantstraat 5
6401 CX HEERLEN
Breda, 20 november 2008
Onze ref.:
Betreft
Hierbij sturen wij u het analyserapport betreffende de klacht van een
borstimplantaat met Iotnummei
Het analyserapport wijst uit dat uw klacht ongegrond is.
Mocht u vragen hebben betreffende deze informatie, aarzelt u dan niet om contact op
te nemen met
Ervan uitgaande u hiermee voldoende te hebben geïnformeerd, verblijven wij,
Met vriendelijke groeten,
RoN Medical Nederland B.V.
1 II.
;er
Bijlagen
THE
BEAUTY
PHILOSOPHY
r
SQ1/üöo3c1
J1]
linpIementaton
ANALYSIS REPORT
29
oct
200S
POLY IMPLkNTS PROTHESES
Pagelof2
1
DATA COLLECTION
PIP file N
Analysis date: 27/10/2008
Distributor:
Hospital: Artrium medisch centrum
Surgeon:
Patient:r
Reason for return: Explantation
Implantation date: 04/06/2003
Explantation date: 29/07/2008
Implaritation time: 5 years
Product identification: IMGHC-TX
Batchlserial number: 15501-174
Volume: 365 cc
INCIDENT REPORTING
The prosthesis was explanted some 5 years after the implantation because of rupture.
SHELL SCHEMA AND PHOTO
No photo taken, implant not received.
ANALYSIS RESULT
Implant not received.
Analyst(s):
Returns & Complaints Manager
[)J
[]
[)
SQ1/14 FOR 8oï
ANALYSIS REPORT
ementation date:
29oct2008
POlY IMPLANTS PROflIE5ES
Page 2 of2
DATA COLLECTION
PIP file N
Analysis date: 27/10/2008
Reason for return: Explantation
Implantation date: 04/06/2003
Explantation date: 29/07/2008
Implantation time: 5 years
IJILI
Hospital: Artrium medisch
centrum
Product identification: IMGHC-TX
Batch 1 serial number: 15501-164
Volume: 365 cc
INCIDENT REPORTING
This explant is the contralateral implantof unit number 15501-1 74.
SHELL SCHEMA AND PHOTO
DOME SIDE
UPPER LEFT
QUADRANT
UPPER RICHT
QUADRANT
LOWER
QUADRANT
LOWER RICHT
QUADRANT
1
ANALYSIS RESULT
Implant without any defect.
Tolerance criteria +/- 2.5 % of the initial weight implant.
Analystf’s):
pagina 1 van 1
306
10.2.e. (gehele document, tenzij anders aangegeven)
Afzender/verzender: IGZ
Van:
Verzonden: maandag 2mei2011 13:53
Aan:
_Dienstpostbus IGZ DenBosch
Onderwerp: FW: drie meldingen Atrium? (documentnr
Bijlagen:
meldingnr
.PDF
Beste collega’s,
Willen jullie deze e-mail hangen onder WPM-nummer:
Dank!
Groet,
Van:
Verzonden: maandag 2 mei 2011 13:48
Aan:
Onderwerp: EW: drie meldingen Atrium?
Ha
voor de melding PIP.
dank
Verzonden: maandag 2 mei 2011 13:09
Aan:
Onderwerp: drie meldingen Atrium?
Beste
11.1
Hoe denk jij hierover?
Met vriendelijke groet,
04-05-20 1 1
?
307
10.2.e. (gehele document)
Inspectie voor de Gezondheidszorg
Ministerie van Volksgezondheid,
Welzijn en Sport
>
Retouradres Postbus 90700 2509 LS Den Haag
Atrium Medisch Centrum Parkstad
T.a.v.
lid Raad van Bestuur
fl
4-k
rOSLUUS
AAA.C
‘U
6401 CX HEERLEN
Werkgebied Zuidwest
wiIh. ‘Jan Prulsenweg 52
Den Haag
Postbus9O700
2509 LS Den 1-laag
T 0703041500
F 070 304 15 70
www.igz.nl
Inlichtingen bij
T (070
Datum
9 mei 2011
Onderwerp
rieldingen aan Rofil door Atrium
Uw kenmerk
Geachte
Uw brief
14 april 2011
Bedankt voor uw brief van 14 april 2011 over de meldingen die door Atrium
Medisch Centrum Parkstad aan Rofil zijn gedaan naar aanleiding van het scheuren
van implantaten.
Ik heb uw meldingen gelegd naast het overzicht dat ik al had van meldingen die
door Rofil conform de wettelijke eisen aan de inspectie waren gemeld. Uw
overzicht bestaat uit drie meldingen, met in totaal vier kapotte implantaten. In het
overzicht dat wij hebben van meldingen die ontvangen zijn van Rofil tref ik in
totaal acht meldingen uit het Atrium aan, met in totaal tien beschadigde
implantaten. De drie meldingen uit uw brief van 14 april 2011 kan ik in dat
overzicht terug vinden. Maar verder overlappen deze beide overzichten elkaar
niet.
Wanneer er toch nog andere meldingen zijn, ontvang ik die graag alsnog van u
binnen drie weken na dagtekening van deze brief.
Gezien uw verantwoordelijkheid voor het leveren van verantwoorde zorg wil ik u
er daarnaast nog op wijzen dat het opsporen en aanschrijven van de patiënten die
nog niet gereageerd hebben op uw recail van groot belang is teneinde
patientschade in de toekomst te vermijden. Ik verwacht uw reactie hierop binnen
zes weken na dagtekening van deze brief.
Pagina 1 van 1
Naam
Adres
1O.2.e.
Ingeschreven in
Infunctietreding
Titel
Bevoegdheid
:Palra Grove Tlouse P. 0. BOX 438, Roadtown,
Tortola, Britse Maagdeneilanden
:Registry of Corporate Affaires te Road Town,
Britse Maaqdeneilanden onder nummer 1534612.
:31—12—2009
:Directeur
:Alleen/zelfstandig bevoegd
308
Alleen geldig indien door de kamer voorzien van een ondertekening.
16—05—2011
Dossiernununer:
20062037
Blad 00003 volqt.
Blad 00003
Woercien, 16—05—2011
Uittreksel is vervaardigd om 15.37 uur
Voor uittreksel
Bron: Uittreksel-informatie lnternet. Geldt niet als uittreksel in de zin van artikel 22 lid 1 van de Handeisregisterwet 2007.
102e (gehe1edmetY
:z2Ö’ 1,
a
9
,
i:
—
J
:
9
j j
309
+r
LJ
medisch centrum porksta
Raad van Bestuur
tel. (045)_
fax (045) 5767474
2509 LLDen Haag
emailadres; [email protected]
datum: 6 juni 2011
Wilt u s.v.p. bij uw reactk
ons kenmerk vermelden.
ons kenmerk:
Betreft: melding M-lmplants van ROFIL
Geachte
Refererend aan uw schrijven van 9 mei jI. wil ik u laten
weten dat alle defecte implantaten,
waarvan u in januari een overzicht ontving, opgestuu
rd zijn naar ROFIL dan wel meegegeven
met de vertegenwoordiger van de firma. Helaas beschikk
en wij niet over correspondentie
dienaangaande. Zoals vermeld ontvingen wij steeds als
antwoord dat de prothese stuk was
maar er werd nooit een oorzaak in het materiaal geconstat
eerd. Als tegemoetkoming werden
de prothesen vergoed.
Wat betreft het opsporen van patiënten die geen gehoor
meer hebben gegeven aan de
controleoproep heeft de Plastische Chirurgie inmiddels laten
weten dat het merendeel van de
patiënten op de oproep heeft gereageerd. Wij realiseren
ons dat er ook patiënten zijn die
inmiddels z verhuisd of mogelijk overleden.
‘lid Raad van Bestuur
Atriurn Mdsch Centrum PorkstDd
Heerlen
Brunssum
Kerkrade
319
certificaten, manuals en conformiteitsverklaringen
risico management m-implants
statement m-implants
ec declaratie
general agreement rmi tuv rheinland
certificat d’examen Ce de la conception pip
ec design examination report rmi silicone breast implant
correspondentie rofil -tuv rheinland inzake design dossier
correspondentie rofil -tuv rheinland inzake design dossier
ec design examination certificate
deviation topic 19
audit report tuv
aanvraag tot ec conform ity
deviations door biotop mediaci voor RMI
verzoek voor certificaten
aanvraag tot ec conformity met product beschrijving
verzoek change legal manufacturer van RMI naar RMN
design dossier report for amendments mdd
revision level
quality manuel procedure
7-4-2004
23-4-2004
23-4-2004
7-4-1999
15-3-2004
5-8-2002
24-5-2004
10-6-2004
22-6-2004
21-9-2004
31-7-2003
7-3-2007
9-3-2007
14-6-2007
14-7-2007
21-6-2007
1 9-7-2007
9-4-2044
18-7-2007
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Certificaten, manuals en conformiteitsverklaringen tuv en snch
Annex certificate m-implants rofil
Annex certificate bellagel implant Hand BIOMED corp
Design examination certificate rofil med int.
Intrekken ce keurmerk tuv aan schreuder
Philoderm incidenten overzicht naar tuv
Verklaring niet meer gebruiken ce keurmer vai
Rofil aan tuv naams wijziging rofil in philoderm
Incidenten overzicht rofil med ni aan tuv
Revisie stand tuv
Declaration of conformity rofil
aan tuv
18-3-2010 SNCH
15-7-2010 SNCH
22-6-2004
16-06-2009
8-4-2009
25-2-2009
14-1-2009
20-10-2008
6-7-2007
—
Naam afzender
1
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nvt
nvt
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0 nvt
27-9-2010
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nvt
0 nvt
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27-9-2010
29-9-2010
27-9-2010
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28-9-2010
29-9-2010
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0 nvt
0 nvt
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27-9-2010
nvt
0 nvt
0 nvt
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27-9-2010
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1
nummer
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0 nvt
27-9-2010
27-9-2010
27-9-2010
27-9-2010
Datum
1
Inventarisatie reacties op tweede IGZ-waarschuwing borstimplantaten
Brief 23 september2010,
10.2.e. (gehele document, tenzij anders aangegeven)
1
10.2.g..
11.1.
10.1.c,
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MRB Fijnmetaalbewerking B.V. te Valkenswaan NEN-EN-ISO

Certificaat

.Be Medical Jagoda Vandyck Abn The Air Management

Nauwkeurigheid van bloedglucosemeters

Plus SW 250 – 255 poly

Protect SW 250 – 255 poly

Opdrachtformulier botgroeistimulatoren

lijst van begunstigers

NEC EA273WMi