Events

Safety Alert for Hyaluronic acid-based implants

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

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
    R1605-220
  • Event Number
    2012DM-0009198
  • Date
    2016-05-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=139
  • 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 has detected that the expiration date of the needles expires three to seven months before the expiration indicated in the box of the syringes, although it does not imply a risk of its use, it has been determined to withdraw the specific product since the sterility of the syringes can not be guaranteed. the needles beyond their expiration date, leading to potential adverse events for patients.

Device

Hyaluronic acid-based implants
  • Model / Serial
    TEOSYAL ULTIMATE, TEOSYAL PURESENSE ULTIMATE, lots TST-142103, TSTL-143902 and TSTL-154704.
  • Product Description
    Hyaluronic acid-based implants containing 3% lidocaine hydrochloride. They are indicated for the filling of the wrinkles and lines, increase the volume of the lips and reshape the facial contour, reducing the slight pain in the injection site.
  • Manufacturer
    Teoxane S.A.

Manufacturer

Teoxane S.A.