Medical Device Alert: Neuro-surgical sponges (patties) manufactured by Codman (MDA/2010/066)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/066 or 2010/007/027/291/012.

Technical aspects
Mojisola Ajeneye or Sally Mounter
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3271/3168
Fax: 020 7084 3106

Email: mojisola.ajeneye@mhra.gsi.gov.uk or sally.mounter@mhra.gsi.gov.uk

Clinical aspects
Dr Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3126
Fax: 020 7084 3111

Email: nicola.lennard@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the Central Alerting System website (external link).

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

Radiopaque strips may be retained in patients.

Codman is recalling surgical sponges (patties) from certain lots (distributed from May 2009 to May 2010 inclusive) because affected products were manufactured with reduced adhesion between the sponges and the blue radiopaque strip.

This may result in the strip becoming detached during surgery.

• Do not use sponges from the affected lots and return unused stock to the manufacturer.
• Follow the advice in the manufacturer’s recall letter (published as a Field Safety Notice in July 2010).
• Consider the need for alternative supply where necessary.

This MDA has been distributed to:

• NHS trusts in England (chief executives)
• HSC trusts in Northern Ireland (chief executives)
• NHS boards in Scotland (chief executives)
• NHS boards and trusts in Wales (chief executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• A&E departments
• All wards
• All theatres
• Neurosurgeons
• Risk managers
• Supplies managers
• Surgeons
• Theatre managers

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• Clinics
• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

Mrs Lynn Heaver
Codman Johnson & Johnson Medical Ltd
European and International Regulatory Affairs Manager

Phone: 01344 871 147
Fax: 01344 871 120

Email: lheaver@its.jnj.com