Events

Field Safety Notices about Coopers Walking Frames

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Sunrise Medical Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2008(04)
  • Date
    2008-04-02
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/coopers-walking-frames&id=768df825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    A number of incidents have been reported to the irish medicines board (imb) relating to the use of these frames. this purpose of this notice is to: make users / prescribers aware of a quality improvement / design change implemented by the manufacturer in july 2006. ensure that the instructions for safe and effective device use are communicated.
  • Action
    Ensure users / prescribers are aware of issues Familiarisation with the instructions for safe and effective device use, in particular the general safety and warning statements in the manufacturers’ instructions for use. Ensure that device is in proper working order before being put into service as these frames can be damaged during shipment or storage. Highlight to users the need for regular inspection of the device for damage or signs of wear in accordance with manufacturers guidelines and where necessary to take appropriate remedial action (in the form of replacement / repair).

Device

Coopers Walking Frames

Manufacturer

Sunrise Medical Limited