Events

Alerta De Seguridad para breast implant monobloc silicone

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 Laboratoires Arion.

¿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
    R1604-164
  • Número del evento
    2008DM-0002042
  • Fecha
    2016-04-20
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=145
  • 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
    In attention to the publication made by the health agencyanvisa, through which informs that as of monday, april 18, 2016, it suspended the importation, distribution, sale and implantation of the mandatory prostheses marcaarion, texturized - type 4, manufactured by the laboratoires arion french company, the measure was published in the official gazette (dou), under resolution 987 / 2016.1it was also suspended the authorization for the use of the certificate of conformity, issued by the bauer falcon institute of quality (ifbq), because the product is not complies with the quality requirements established by this certifying organism. invima warns as a precautionary measure, due to the high impact on public health that implantation can generate in potential users of a medical device with the described quality problems.

Device

breast implant monobloc silicone
  • Modelo / Serial
    Textured - Type 4, all lots.
  • Descripción del producto
    For aesthetic reconstructive surgery and in cases of augmentation mammoplasty.
  • Manufacturer
    Laboratoires Arion

Manufacturer

Laboratoires Arion