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MDA/2008/013 - Heel & Elbow and Heel & Ankle Gelbodies used to help prevent pressure ulcers. Manufactured by Trulife

Document details:

Type: Medical Device Alert
Series No: MDA/2008/013
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

Page 1

Issued: 10 March 2008 at 11:00
Ref: MDA/2008/013

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Heel & Elbow and Heel & Ankle Gelbodies used to help prevent pressure ulcers. Manufactured by Trulife.

>Page 2

Problem:
Risk of broken skin, friction burns, and redness from using Heel & Elbow and Heel & Ankle Gelbodies over a period of prolonged continuous use.

>Page 2

Action by:
All those involved in the provision, prescription and use of Gelbodies. In particular nurses and care staff.
 

Action:

  • Trace all Trulife Heel & Elbow and Heel & Ankle Gelbodies purchased before November 2007.
  • Obtain a copy of the latest instructions for use from the manufacturer available on their website www.trulife.com.
  • Check that the Gelbodies are not being used for more than 12 hours in any 24 hour period.
  • Check that any Gelbody in use is of an appropriate size and where necessary replace with a different size.
 

Distributed to:

NHS trusts in England - Chief Executives*
OFSTED  - Directors of Children's Services
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*
Social services in England - Directors*

* via CE Bulletin

>Page 2

Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for CSCI and Healthcare Commission.

>Pages 2-3



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 10 April 2008
Deadline (action complete): 10 June 2008


Page last modified: 10 March 2008