FIX TRAY ADHESIVE

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT RECEIVED BURNS ON THE MOUTH AND LIPS AFTER A PROCEDURE WAS PERFORMED USING AFFINIS SILICONE IMPRESSION MATERIAL SECURED TO THE TRAY USING FIX TRAY ADHESIVE; THE PATIENT WAS ADMINISTERED AN ANTIBIOTIC AND MOUTH RINSE AS A RESULT.

Additional Manufacturer Narrative

THE DIRECTIONS FOR USE WARN THAT THE MATERIAL IS IRRITATING TO THE EYES, MUCOSA, AND SKIN AND ALSO THAT ALLERGIC REACTIONS MAY RESULT IN SUSCEPTIBLE INDIVIDUALS. WHILE ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDING UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL, THE SYMPTOMS REPORTED IN THIS CASE APPEAR TO BE MORE CONSISTENT WITH IRRITATION/BURNING RESULTING FROM CONTACT WITH THE SKIN/MUCOSA, RATHER THAN A SENSITIZATION REACTION. THE DIRECTIONS FOR USE ALSO INDICATE THAT THE TRAY ADHESIVE SHOULD BE USED WITH ALGINATE IMPRESSION MATERIALS ONLY; THE ADHESIVE WAS USED WITH A SILICONE MATERIAL INT HIS EVENT. HOWEVER, SINCE AN ANTIBIOTIC WAS ADMINISTERED IN THIS CASE, THE DEVICE WAS RETURNED FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.