DS UNIV STAIN & OVERGLAZE KIT

Additional Manufacturer Narrative

ADDITIONAL INFORMATION RECEIVED: FAILURE MODE: ADVERSE EVENT. ROOT CAUSE: NOT DETERMINED, BASED ON EVALUATION RESULTS FOR DATA REVIEW AND DOCUMENTATION. NO SAMPLES WERE RECEIVED FROM CUSTOMER TO BE TESTED/EVALUATED. NO ADDITIONAL INFORMATION ABOUT POTENTIAL ALLERGIC REACTION WAS RECEIVED FROM CUSTOMER; ALLERGIC REACTION CHECKLIST WAS NOT RETURNED. CONCLUSION CODE: INDETERMINABLE. CALLED TO THE DENTIST REGARDING THE CASE. THE RECEPTIONIST SAID THAT IT TURNS OUT THAT THE PATIENT WAS ALLERGIC TO THE GC FUJI PLUS CAPSULES. THEY DID NOT HAVE ANY FURTHER INFORMATION REGARDING THE CASE OR THE MATERIALS WHICH THEY DO NOT HAVE IN THEIR POSSESSION.

Additional Manufacturer Narrative

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 IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT WHILE USING DS UNIV STAIN & OVERGLAZE KIT ALLEGEDLY THE PATIENT HAD AN ALLERGIC REACTION. THE PATIENT WAS SEEN BY AN ALLERGIST. FURTHER INFORMATION REQUESTED.