Testicular implants and inflatable vaginal stents – temporary suspension of the CE certificate
Manufactured by Coloplast A/S – temporary suspension of the CE certificate due to particles found on some implantable devices made by their subcontractor Silimed lndustria de lmplantes Ltda - MDA/2015/036
Action
- Do not implant affected devices
- Quarantine devices
- Await further advice from the manufacturer and/or MHRA
- If patients enquire they can be reassured that this situation is being investigated as a matter of priority with our European counterparts to decide on further action. However, if they would like to be kept up to date they can register for email updates and they will be kept informed.
Deadlines for actions
Actions underway: 22 October 2015, actions complete: 29 October 2015
Device details
All batches of the following devices manufactured by Coloplast A/S are affected:
Testicular implants, product codes: PR3001, PR3002, PR3003, PR3004, PR3005
Vaginal stents – inflatable, product codes: VS3020, VS3022, VS3024, VS3026
Problem/background
The German medical device regulatory authority informed MHRA on Friday 18 September 2015 that a German notified body had temporarily suspended the marketing and distribution of all medical devices manufactured by Silimed lndustria de lmplantes Ltda.
A recent inspection of the manufacturing facility by the notified body identified particles on the surface of some devices. See MHRA’s alert MDA/2015/034 published on Friday 25 September 2015.
It has subsequently been established that testicular implants and vaginal stents manufactured by Coloplast A/S are made under sub-contract by Silimed lndustria de lmplantes Ltda and so are also affected by the temporary suspension.
MHRA is investigating in collaboration with other European regulators and recommends that none of these devices should be implanted until further advice is issued.
The manufacturer issued a field safety notice (FSN) dated 9 October 2015.
Manufacturer contact
Coloplast A/S
Tina Gotschalk
Holtedam 1
Humlebæk
3050
Denmark
Telephone: +45 4911 3339
Email: vigilance@coloplast.com
Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Cosmetic surgeons
- Day surgery units
- Dermatologists
- General surgeons
- General surgery
- General surgical units, directors of
- Gynaecologists
- Gynaecology departments
- Gynaecology nurses
- Medical device safety officers
- Medical directors
- Obstetricians
- Obstetrics and gynaecology departments
- Obstetrics and gynaecology directors
- Obstetrics departments
- Obstetrics nurses
- Paediatric surgeons
- Paediatric surgery, directors of
- Plastic and reconstructive surgeons
- Risk managers
- Supplies managers
- Theatre managers
- Theatre nurses
- Theatres
- Urological surgeons
- Urological surgery, directors of
- Urology departments
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Independent treatment centres
- Private medical practitioners
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2015/036 or 2015/010/009/299/003
Technical aspects
Ian Smith or Bayode Adisa
MHRA
Telephone: 020 3080 7306 / 7723
Email: ian.smith@mhra.gsi.gov.uk or bayode.adisa@mhra.gsi.gov.uk
Clinical aspects
Dr S Jagdish
MHRA
Telephone: 020 3080 7187
Email: soundararajan.jagdish@mhra.gsi.gov.uk
Reporting adverse incidents in England
Northern Ireland
Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
CMO Group,
Department of Health, Social Services and Public Safety
Telephone: 028 9052 3868
Fax: 028 9052 3900
Email: NIAIC@dhsspsni.gov.uk
Northern Ireland Adverse Incident Centre (NIAIC)
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website.
Scotland
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Telephone: 0131 275 7575
Fax: 0131 314 0722
Email: nss.iric@nhs.net
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Private facilities providing care to private clients report to the Care Inspectorate and MHRA.
Wales
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Welsh Government
Telephone: 02920 823 624/02920 825 510
Email: Haz-Aic@wales.gsi.gov.uk
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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