Events

Alerta De Seguridad O Notificaciones De Seguridad para Standard Offset Cup Impactor

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 Greatbatch 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
  • ID del evento
    MDA/2014/031
  • Número del evento
    CON437749
  • Fecha
    2014-07-24
  • Fecha de publicación del evento
    2014-07-24
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON437749?tabName=allTabs
  • 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
  • Causa
    Potential for infection from inadequately sterilized devices. the manufacturer has validated new sterilization parameters for these devices to address this issue. these parameters are provided in the manufacturer’s field safety notice (fsn) issued in march 2014. greatbatch originally sent a notification in january 2014, with one acceptable sterilization parameter, (validated to a sterility assurance level (sal) of at least 10-6). greatbatch has now validated an additional sterilization parameter for use with their device. both acceptable parameters are provided in the updated fsn dated march 2014. the mhra is issuing this medical device alert to ensure that all users are aware of the manufacturer’s updated fsn.
  • Acción
    Identify affected devices. Follow the updated sterilization instructions described in the FSN. All staff involved in sterilization of these devices. All orthopaedic staff that use these devices.

Device

Standard Offset Cup Impactor
  • Modelo / Serial
  • Descripción del producto
    Greatbatch Medical: Standard Offset Cup Impactor
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical