Alerta De Seguridad O Notificaciones De Seguridad para Testicular implants and inflatable vaginal stents

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 Coloplast A/S.

¿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
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • 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
    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. See MHRA’s alert MDA/2015/034 published on Friday 25 September 2015.It has subsequently been established that testicular implants and vaginal stents manufactured by Coloplast A/S are made under sub-contract by Silimed lndustria de lmplantes Ltda and so are also affected by the temporary suspension.MHRA is investigating in collaboration with other European regulators and recommends that none of these devices should be implanted until further advice is issued.The manufacturer issued a field safety notice (FSN) dated 9 October 2015.
  • Causa
    Manufactured by coloplast a/s – temporary suspension of the ce certificate due to particles found on some implantable devices made by their subcontractor silimed lndustria de lmplantes ltda - mda/2015/036.
  • Acción
    Do not implant affected devices Quarantine devices Await further advice from the manufacturer 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.


  • Modelo / Serial
  • Descripción del producto
    All batches of the following devices manufactured by Coloplast A/S are affected:Testicular implants, product codes: PR3001, PR3002, PR3003, PR3004, PR3005Vaginal stents – inflatable, product codes: VS3020, VS3022, VS3024, VS3026
  • Manufacturer


  • Dirección del fabricante
    Coloplast A/S Tina Gotschalk Holtedam 1 Humlebæk 3050 DenmarkTelephone: +45 4911 3339Email:
  • Empresa matriz del fabricante (2017)
  • Source