Events

Avis De Sécurité sur Coopers Walking Frames

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Sunrise Medical Limited.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2008(04)
  • Date
    2008-04-02
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/coopers-walking-frames&id=768df825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "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."
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Coopers Walking Frames
  • Manufacturer
    Sunrise Medical Limited

Manufacturer

Sunrise Medical Limited