Events

Alerte De Sécurité sur coopers walking frames

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Sunrise Medical.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-12-07
  • Date de publication de l'événement
    2012-12-07
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121207a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: coopers walking frames the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device alert concerning coopers walking frames, manufactured by sunrise medical. the affected products had dispatch dates from 20 august to 02 october 2012 inclusive. the affected product codes were 7321c, 7323c, 7325c, 7331c, 7333c, 7335c, 7341c, 7343c, 7351c and 7353c. according to the manufacturer, there was risk of falls due to the walking frame becoming unstable. the rear screws that fasten the c-shaped lower bar to the frame may fail because of a manufacturing fault. the failure usually occurred a short time after assembly. mhra had the following advice: to identify affected devices and users should undertake a visual check of affected devices located in stores. all rear screws should be checked to ensure that they are present, not loose or broken. devices that are found to have missing, broken or damaged screws are to be quarantined and not used. users were advised to return damaged devices to the manufacturer for replacement or corrective action. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con213178 if you are in possession of the product, please contact your supplier for necessary actions. posted on 7 december 2012.

Device

coopers walking frames
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Coopers Walking frames
  • Manufacturer
    Sunrise Medical

Manufacturer

Sunrise Medical