WHILE IT IS UNKNOWN IF THE DEVICE 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 MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.
D
Patient 1
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO ALADDIN FLOW COMPOSITE MATERIAL. THE PATIENT HAD A SEALANT PUT ON HER TOOTH IN (B)(6) 2015 AND FOR APPROXIMATELY 1 DAY SHE HAD NUMBING AND A BURNING SENSATION IN HER MOUTH. ON (B)(6) 2016, THE PATIENT HAD A SEALANT PUT ON ANOTHER TOOTH, USING THE SAME MATERIAL. THIS TIME, THE PATIENT EXPERIENCED THE NUMBNESS ALL AROUND HER LIPS, ALONG WITH A BURNING SENSATION AND TIGHTNESS FEELING. SHE ALSO STATED THAT THERE WAS SWELLING INSIDE HER MOUTH AND AN AREA OF SKIN THAT LOOKS "BLEACHED" (LIGHTER IN COLOR) AND HER EYES WERE VERY WATERY. THERE WAS NO REPORT OF TREATMENT FOR THE REACTION AS OF THIS MDR EVALUATION.