Safety Alert for Curatec adhesive film

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Lm Farma Industria E Comercio Ltda.

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
    R1612-579
  • Event Number
    2014DM-0012173
  • Date
    2016-12-15
  • 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 states that there is a presence of fragments of metal in the rayon, due to the breakage of the needle during the process of tissue externalization, leading to possible adverse events being presented to patients.

Device

  • Model / Serial
    Lot 16042803
  • Product Description
    CURATEC FILME SIMEX is an adhesive film designed to fix the primary dressing, such as gauze or foam, and serves as a base for fixing the drainage during the assembly of the therapy system by negative pressure. Promotes the sealing of the medium to help in the formation of vacuum during closure.
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    NIDFSINVIMA