Events

Safety Alert for teosyal products

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Teoxane.

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
  • Date
    2014-06-19
  • Event Date Posted
    2014-06-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140619.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: teoxane teosyal products the health canada posted a medical device safety alert concerning teosyal, teosyal meso, teosyal kiss, teosyal first lines, teosyal ultra deep, teosyal ultimate, teosyal puresense ultra deep, teosyal puresense kiss, teosyal puresense deep lines, teosyal puresense global action, teosyal puresense first lines, teosyal puresense redensity i and teosyal puresense redensity ii, manufactured by teoxane. according to the alert, a 48-year-old female experienced an anaphylactic collapse with low blood pressure after injection of hyaluronic acid dermal filler with lidocaine. in response to the incident, the manufacturer will update the instructions for use as follows: the first change, applicable to all teosyal products, is the addition of a sentence related to the risks of anaphylactic shock in the side effects paragraph. the second change concerns only teosyal ultra deep and teosyal puresense ultra deep and deals with a modification of the injection depth. for further details, please refer to health canada website http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/40073r-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted on 19 jun 2014.

Device

teosyal products
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Teoxane Teosyal products
  • Manufacturer
    Teoxane

Manufacturer

Teoxane