Events

Safety Alert for condoms M

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Profilatex S.A. de C.V..

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
    R1706-211
  • Event Number
    2010DM-0005298
  • Date
    2017-06-08
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=84
  • 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
    The invima analysis laboratory reported that a sample of the referenced device does not comply with some parameters of the microbiological tests, because it is out of specifications, leading to potential adverse events occurring in its use.

Device

condoms M
  • Model / Serial
  • Product Description
    Employees to reduce the risk of transmission of HIV infection (AIDS) and other sexually transmitted infections. Employees in the prevention of pregnancy and family planning.
  • Manufacturer
    Profilatex S.A. de C.V.

Manufacturer

Profilatex S.A. de C.V.