Events

Safety Alert for Genefill

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Biopolymer Gmbh & Co Kg.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1602-72
  • Event Number
    2012DM-0009469
  • Date
    2016-02-23
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=155
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    It is evident in the labeling, that the current manufacturer of the referenced product, is not the manufacturer authorized by the invima in the sanitary registry, constituting a transgression to the regulations applicable to the medical devices that are imported.

Device

Genefill
  • Model / Serial
    GENEFILL DX, GENEFILL FINE, GENEFILL ULTRA, GENEFILL SOFT, all lots.
  • Product Description
    GENEFILL is implanted in the intermediate dermal tissue as a complement to the intercellular matrix and intradermal tissue and to restore the lost anatomical structures of the skin. It is used to replace the volume (filling of folds), folds of medium to great depth, folds of lip, increase of the volume of the lips, folds of the eyebrows.
  • Manufacturer
    Biopolymer Gmbh & Co Kg

Manufacturer

Biopolymer Gmbh & Co Kg
  • Source
    NIDFSINVIMA