BRACE GARD
Received May 12, 2010 · Event occurred Apr 9, 2010
Report 1036212-2010-00062 · MDR key 1692004
Device
Manufacturer
Dentsply Raintree Essix GlenroeCatalog number
79BG4
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Swelling
Narrative
Additional Manufacturer Narrative
WHILE IT IS UNKNOWN IF THE WAX USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WAS RUSHED TO THE EMERGENCY ROOM AFTER USE OF BRACE GARD DUE TO THE PATIENT'S FACE BEING SWOLLEN AND THE EYES SWELLING SHUT; TREATMENT WAS ADMINISTERED AT THE ER. THE PATIENT PRESENTED TO THE OFFICE THREE DAYS LATER AND WAS REPORTED AS BEING OKAY.