Alerta De Seguridad O Notificaciones De Seguridad para Wheeled and non-wheeled walking frames (all models)

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Patterson Medical.

¿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
    Safety alert / Field Safety Notice
  • Número del evento
    MDA/2013/060
  • Fecha
    2013-08-01
  • Fecha de publicación del evento
    2014-12-17
  • País del evento
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
    Potential for detachment of the wheels and/or inadequately tightened screws, which may cause the user to fall.Frames of specific batches produced from January 2013 to March 2013 may not have been manufactured to specification.The manufacturer issued a Field Safety Notice (158Kb) in May 2013, but has not had confirmation from a significant number of customers that they have received and acted upon this information.
  • Causa
    (patterson medical) may cause the user to fall. (mda/2013/060).
  • Acción
    Ensure that those responsible for provision and maintenance of these devices:identify affected devices perform the checks and actions detailed in the manufacturer’s Field Safety Notice (158Kb) complete the reply letter and return it to Patterson Medical.

Device

  • Modelo / Serial
  • Descripción del producto
    Wheeled and non-wheeled walking frames (all models).Manufactured by Patterson Medical.Batch codes from DMW12013 to DMW82013 inclusive.Note - paediatric walking frames manufactured by Patterson Medical are not affected.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    ManufacturerPatterson Medical Customer Services North Road Bridgend Industrial Estate Bridgend Wales, CF31 3TP Tel:    0844 412 4330 Fax:   0844 873 0100Email:    retail.sales@pattersonmedical.com
  • Empresa matriz del fabricante (2017)
  • Source
    MHRA