Events

Safety Alert Or Field Safety Notices for Turning aids: ReTurn 7400 and ReTurn 7500

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Handicare AB.

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
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2014/025
  • Event Number
    CON432862
  • Date
    2014-07-02
  • Event Date Posted
    2014-07-02
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON432862?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    The wing handle on the ladder part of the turning aid may become loose, with a risk of harm to the patient and the person operating the device. the manufacturer has developed an inspection protocol, which is set out in its field safety notice (fsn) dated 19 march 2014. handicare has not had sufficient confirmation from users that they have received and acted upon the information contained in the fsn.
  • Action
    Identify any affected devices as described in the Field Safety Notice. Where appropriate, remove affected components and contact Handicare for replacements. If you service or recondition these devices, make sure you use the latest version of the service manual to inspect the wing handles, catches and ladders.

Device

Turning aids: ReTurn 7400 and ReTurn 7500
  • Model / Serial
  • Product Description
    Turning aids: ReTurn 7400 and ReTurn 7500. Specific design is affected. What is affected: The spare part 'wing handles', article number 7322, delivered from June 2009 to July 2011 inclusive. Any ReTurn 7400 or ReTurn 7500 with the ladder attached to the chassis, delivered until May 2011, might have the affected wing handle (see FSN for further details).
  • Manufacturer
    Handicare AB

Manufacturer

Handicare AB