Events

Alerta De Seguridad O Notificaciones De Seguridad para Implantable medical devices manufactured by Silimed lndustria de lmplantes Ltda

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 manufacturer #17429.

¿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/2015/034
  • Fecha
    2015-09-25
  • Fecha de publicación del evento
    2015-09-25
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/implantable-medical-devices-manufactured-by-silimed-temporary-suspension-of-the-ce-certificate
  • 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
    The German medical device regulatory authority informed MHRA on Friday 18 September 2015 that a German notified body had temporarily suspended the marketing and distribution of all medical devices manufactured by Silimed lndustria de lmplantes Ltda.A recent inspection of the manufacturing facility by the notified body identified particles on the surface of some devices.MHRA is investigating in collaboration with other European regulators and recommends that none of these devices should be implanted until further advice is issued.
  • Causa
    Suspension due to particles found on some devices (mda/2015/034).
  • Acción
    Do not implant/use affected devices Quarantine devices Await further advice from the distributor(s) and/or MHRA If patients enquire they can be reassured that this situation is being investigated as a matter of priority with our European counterparts to decide on further action. However, if they would like to be kept up-to-date they can register for email updates and they will be kept informed.

Device

Implantable medical devices manufactured by Silimed lndustria de lmplantes Ltda
  • Modelo / Serial
  • Descripción del producto
    The following devices distributed in the UK by Eurosurgical are affected:silicone implants for plastic surgery: breast implants, pectoral implants, gluteal implants, calf implants, implants for hand surgery, tissue expanders, facial implants, nostril retainers, suspension sheets for breast surgery silicone invasive devices: sizers for silicone implants silicone implants for general surgery: blocks and sheetsThe following devices distributed in the UK by Genesis Medical are affected:implants for urology: testicular implants, penile implants, vaginal stents and periuretheral constrictors
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429