Events

Alerte De Sécurité sur ProLift S 222 Standsupport Slings

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

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
    2013-12-24
  • Date de publication de l'événement
    2013-12-24
  • 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_20131224a.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: novacare prolift s 222 standsupport slings the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning prolift s 222 standsupport slings, manufactured by novacare. details of affected products are as follows: model no.: sizes s, m and l lot no.: all production date: september 2012 according to the manufacturer, the internal quality control system has found a problem with slings produced for the prolift s222 sit-to-stand hoist as from september 2012. some slings have not been correctly sewn. the strap which holds the buckle for the back support could tear under load. this could lead to the patient falling backwards out of the hoist and therefore a high security risk exists. the manufacturer advises customers to check the production date on the sewn on label. all slings will be inspected by the manufacturer’s quality control department and either revised or replaced and then returned to customers. for details, please refer to mhra websitehttp://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con355483 if you are in possession of the product, please contact your supplier for necessary actions. posted on 24 december 2013.

Device

ProLift S 222 Standsupport Slings
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Novacare ProLift S 222 Standsupport Slings
  • Manufacturer
    Novacare

Manufacturer

Novacare
  • Source
    DH