DEVICE: Durewall handling belt supplied in the UK by Prism Medical. Order Codes DUR03, DURMED AND DURLGE
MANUFACTURER: The product is labelled as manufactured by Etac, Etac Immedia and Immedia with article numbers (IM) 8010509, 8010513, 8013009, 8013013, 8015013 and 8017015. These belts were supplied before January 2011.
As you are aware, the Medicines and Healthcare products Regulatory Agency is an Executive Agency of the Department of Health that is responsible for the regulation of medical devices. Part of our function in protecting public health is to ensure that any problems associated with medical devices are brought to the attention of all healthcare workers that need to be aware. This is contained in a Medical Device Alert which sets out the issue, background and action to be taken.
Please find a link to the Medical Device Alert that relates to the above device.
The Alert has been circulated to all relevant Trusts for onward distribution to the relevant clinicians. Please do not hesitate to contact me if you have any problems with the message or wish clarification.
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON123274
Yours sincerely
Jonathan Plumb
Jonathan Plumb
Nursing Advisor, Devices Clinical
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1S 9SZ