Safety Alert for Non-stick barrier SEPRAFILM

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

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
    I1605-208
  • Event Number
    2012DM-0008884
  • Date
    2016-05-18
  • Event Country
  • Event Source
    INVIMA
  • Event Source URL
  • 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 informs that it is in the process of renewal of the ce marking, for which reason it has decided to make some modifications on the instructions of use of the medical device, in order to avoid that potentially adverse events occur on the patients.

Device

  • Model / Serial
    All lots
  • Product Description
    Supplement of abdominal, pelvic or thoracic surgery to reduce the incidence, extent and severity of postoperative adhesions in the area of placement and reduce obstruction adherence of the small intestine when placed in the abdomen.
  • Manufacturer

Manufacturer

  • Source
    NIDFSINVIMA