Events

Alerta De Seguridad para breast prostheses filled with reticulated silicone gel

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 Cereplas.

¿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
    R1402-87
  • Número del evento
    INVIMA 2008DM-0001821
  • Fecha
    2014-02-24
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=208
  • 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
    Affirms that the health agency of france (ansm) found that the sterilization processes used in the manufacture of this device have not been fully validated in accordance with international regulations for which you must suspend the marketing and use of them until the investigation determines that they are safe for its use or sedecida the definitive withdrawal of the product from the market, additionally states that have not yet been identified health risks associated with the implanted prostheses.

Device

breast prostheses filled with reticulated silicone gel
  • Modelo / Serial
  • Descripción del producto
    It is used in aesthetic, reconstructive or reconstructive surgeries such as: breast reconstruction after a mastectomy, breast augmentation for esthetic purposes, correction of the breasts by various congenital or acquired anomalies: dissymmetry, amasthesis, aplasia, hypomastia, hypoplasia; replacement of an old or defective implant after its removal.
  • Manufacturer
    Cereplas

Manufacturer

Cereplas
  • Empresa matriz del fabricante (2017)
    Cereplas
  • Source
    NIDFSINVIMA