PROTRACTION FACEMASK
Received Feb 26, 2013
Report 2418500-2013-00001 · MDR key 2987613
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Hypersensitivity/Allergic reaction
Narrative
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED THAT THE PT EXPERIENCED AN ALLERGIC REACTION TO THE PROTRATION FACEMASK ON THEIR CHIN. NO MEDICAL ATTENTION WAS NECESSARY AND THE AFFECTED CLEARED UP WITH IN 24 HOURS.
Additional Manufacturer Narrative
WHILE IT IS UNK IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'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 MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.