Events

Notificaciones De Seguridad De Campo acerca de Drive Medical Products - Drive WA007 Rollators, Drive Medical Nimbo Paediatric Walkers & Endres Riviera Bathlifts

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Drive Medical Limited.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2012(03)
  • Fecha
    2012-04-20
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    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
  • Notas / Alertas
    "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."
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / Serial
  • Descripción del producto
    Drive Medical Products - Drive WA007 Rollators, Drive Medical Nimbo Paediatric Walkers & Endres Riviera Bathlifts
  • Manufacturer
    Drive Medical Limited

Manufacturer

Drive Medical Limited