Events

Recall of Wilson Frame Tempur Pedic Pad Set

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00496-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00496-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    An audit of the manufacturing process showed a variance in the construction of the model 5319-37 pads that may allow the patient to contact the underlying carbon fibre structure of the wilson frame and could lead to pressure injury.
  • Action
    LifeHealthcare is advising users to discontinue use of any Wilson Frame device with pad model 5319-37 and segregate the pads for return to LifeHealthcare. For replacement, users can choose either model 5319-36 Replacement Frame Gel pads or Tempur-Pedic pads.

Device

Wilson Frame Tempur Pedic Pad Set
  • Model / Serial
    Wilson Frame Tempur Pedic Pad SetProduct Codes: 5319G Radiolucent Wilson Frame 5321G Radiolucent Wilson Frame5319-37 Replacement Wilson Frame Tempur Pedic PadsPad Manufacture Dates: 1 December 2016 to 20 March 2017ARTG Number: 183116
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd