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|Type:||Medical Device Alert|
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/083 or 2010/002/019/261/001
James McVeigh or Brian Mather
Medicines & Healthcare products Regulatory Agency
Centre for Assistive Technology
241 Bristol Avenue
Blackpool FY2 0BR
Tel: 01253 596 000
Fax: 01253 596 177
How to report adverse incidents
Please report via the MHRA website
Further information about CAS can be found on the CAS website (external link)
Alerts in Northern Ireland will continue to be distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Dundonald BT4 3SQ
Tel: 02890 523 704
Fax: 02890 523 900
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
1 South Gyle Crescent
Edinburgh EH12 9EB
Tel: 0131 275 7575
Fax: 0131 314 0722
Enquiries in Wales should be addressed to:
Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cardiff CF10 3NQ
Tel: 029 2082 3922
Durewall handling belt supplied in the UK by Prism Medical, order codes DUR03, DURMED and DURLGE.
The product is labelled as manufactured by Etac, Etac Immedia or Immedia with article numbers (IM) 8010509, 8010513, 8013009, 8013013, 8015013 and 8017015. These belts were supplied before January 2011.
The instructions for use (IFU) did not provide clear guidance on how to re-thread the buckle nor the checks to be carried out before each use. The cleaning instructions have also been updated.
The manufacturer issued a Field Safety Notice (FSN) (25Kb) for this device on 16 May 2011, but has not had sufficient confirmation from users that they have received and acted on this information.
This MDA has been sent to:
Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:
Liaison officers for onward distribution to all relevant staff including:
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
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: email@example.com and requesting this facility.
Anette Repenning Raun
Kista Science Tower
SE-164 51 Kista
Tel: + 46 371 58 73 30
Fax: + 46 371 58 73 90
If you have any comments or feedback on this Medical Device Alert, please email us at: firstname.lastname@example.org