CERAMX SPECTRA ST COMP HV A3

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 WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT PATIENT EXPERIENCED ALLERGIC REACTION/BURNS IN THE MOUTH AFTER BEING EXPOSED TO CERAMX SPECTRA ST COMP HV A3. NO INFORMATION ABOUT THE TREATMENT, INCLUDING OTHER PRODUCTS USED, LOCATION, SEVERITY, DURATION OF SYMPTOMS, OR THE PATIENT¿S MEDICAL HISTORY HAS BEEN PROVIDED.