Events

Alerta De Seguridad para Mentor Breast Implants

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Mentor Medical System B.V. || Mentor || Perouse Plastie.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    R1709-422
  • Número del evento
    2011DM-0007151
  • Fecha
    2017-09-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=72
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has been able to identify that the labeling of the product does not correspond to the label engraved by the medical device, the latter is the precise description of the product, leading to possible confusions and delays in the procedures.

Device

Mentor Breast Implants
  • Modelo / Serial
    354-5350, 354-5240, lots 7464368, 7464364
  • Descripción del producto
    Cosmetic enhancement, immediate or delayed breast reconstruction after mastectomy, reconstruction after treatment of breast cancer to mastectomy, revision due to complications or other undesirable results of a previous mastectomy intervention or other treatments other than mastectomy, post-traumatic reconstruction defined as total or partial removal of one or both breasts by means of a surgical intervention (for any reason or as a consequence of the trauma itself).
  • Manufacturer
    Mentor Medical System B.V. || Mentor || Perouse Plastie

Manufacturer

Mentor Medical System B.V. || Mentor || Perouse Plastie