Important Safety Alerts

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