Events

Safety Alert for FLEXI-SEAL Fecal Management System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Convatec Dominican Republic Inc || Convatec Inc || Convatec A Division Of E.R. Squibb & Sons, L.L.C..

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
    R1405-200
  • Event Number
    2007DM-0000993
  • Date
    2014-05-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=204
  • 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 manufacturer determined that the previous systems have a poor performance of the auto - valve because it is not constant in terms of inflation and the deflation of the balloon retention, leading to the generation of possible adverse events on the patient.

Device

FLEXI-SEAL Fecal Management System

Manufacturer

Convatec Dominican Republic Inc || Convatec Inc || Convatec A Division Of E.R. Squibb & Sons, L.L.C.