Events

Avis De Sécurité sur Drive Medical Products - Drive WA007 Rollators, Drive Medical Nimbo Paediatric Walkers & Endres Riviera Bathlifts

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Drive 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
    SN2012(03)
  • Date
    2012-04-20
  • 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=/drive-medical-products---drive-wa007-rollators-drive-medical-nimbo-paediatric-walkers-endres-riviera-bathlifts&id=d27ff825-9782-6eee-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
    Drive medical initiated three field safety corrective actions in august and september 2011 for the following products:  1. drive wa007 rollators  2. drive medical nimbo paediatric walkers  3. endres riviera bathlifts  the irish medicines board (imb) is aware that drive medical and their irish distributors/suppliers have been unsuccessful in their attempts to date to locate all affected devices in ireland affected by these field safety corrective actions.
  • Action
    The IMB advises that users/suppliers:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected products.  3. If you / your institution have affected products, follow the manufacturer’s recommendations as outlined in the attached field safety notice(s) and ensure that the corrective actions are completed on all affected medical devices.

Device

Drive Medical Products - Drive WA007 Rollators, Drive Medical Nimbo Paediatric Walkers & Endres R...
  • Modèle / numéro de série
  • Description du dispositif
    Drive Medical Products - Drive WA007 Rollators, Drive Medical Nimbo Paediatric Walkers & Endres Riviera Bathlifts
  • Manufacturer
    Drive Medical Limited

Manufacturer

Drive Medical Limited