Events

Notificaciones De Seguridad De Campo acerca de Coopers Walking Frames

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Sunrise 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
    SN2008(04)
  • Fecha
    2008-04-02
  • 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=/coopers-walking-frames&id=768df825-9782-6eee-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
    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.
  • Acción
    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

Manufacturer

Sunrise Medical Limited