Consumers and health professionals are advised that Otto Bock Australia Pty Ltd, in consultation with the TGA, has undertaken a recall of Aerius/Aerial and Aerius/Aerial Active wheelchair seat cushions.
Routine testing has found that the foam within these cushions becomes more flammable after it has been washed many times in a washing machine at high temperatures. While washing the entire cushion (cover and foam) in a washing machine is contrary to the product's Instructions for Use, Otto Bock Australia Pty Ltd is recalling all affected cushions as a precaution.
Neither the TGA nor Otto Bock has received any adverse event reports involving the affected cushions.
Information for consumers
Otto Bock Australia Pty Ltd, or a distributor, is contacting all affected wheelchair cushion users to arrange for the cushion to be returned. The company will supply a new model of cushion.
You are reminded of the importance of reading the Instructions for Use before using the cushion.
If you, or someone you care for, uses an Otto Bock Aerius/Aerial or Aerius/Aerial Active cushion and you have not already been contacted, telephone Active Rehabilitation Equipment on 03 5441 8722 to arrange for the cushion to be returned.
Information for health professionals
Otto Bock Australia Pty Ltd, or a distributor, is contacting all affected Aerius/Aerial or Aerius/Aerial Active wheelchair cushion users to arrange for cushion replacement.
If you are treating a patient who uses an affected Otto Bock cushion, make sure they are aware of this issue and advise them to telephone Active Rehabilitation Equipment on 03 5441 8722 to arrange for the cushion to be returned.
Reassure patients that the risk is small and there have been no reported incidents to date. Remind them to read the Instructions for Use before using any medical device.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.