Events

Safety Alert for Gastrointestinal lining with placement and extraction system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by GI Dynamics, Inc.

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
    I1503-106
  • Event Number
    2013DM-0010120
  • Date
    2015-03-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=183
  • 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 states that it will make changes in its use indications, specifying the patient's conditions and possible side effects to clarify the indication of obesity and include a restriction for patients with a body mass index (bmi) ≥ 30 kg / m2, with the objective to avoid presenting possible adverse events on patients.

Device

Gastrointestinal lining with placement and extraction system
  • Model / Serial
    40-10-00364
  • Product Description
    The gastrointestinal lining ENDOBARRIER with placement system of GI DYNAMICS is used for the treatment of type 2 diabetes and / or obesity. It appears sterile and consists of a gastrointestinal lining (anchoring and lining) preloaded from a catheter that places the lining in the proximal intestine. They are available sterile (ethylene oxide) or non-sterile.
  • Manufacturer
    GI Dynamics, Inc

Manufacturer

GI Dynamics, Inc