INTEGRITY TEMP GRIP REFILL PK

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 WAS REPORTED THAT A PATIENT MAY HAVE EXPERIENCED AN ADVERSE REACTION AFTER UNDERGOING A DENTAL PROCEDURE THAT INVOLVED THE USE OF INTEGRITY TEMP GRIP. THE PATIENT PRESENTED WITH ULCERATIONS AND PEELING LOOK TO GINGIVA, BURNING SENSATION, AND PAIN AND HAS AN ALLERGY TO ACRYLATES AND SULFA DRUGS. DOCTOR REPORTS THAT PATIENT WAS TAKING BENADRYL AND DOCTOR PRESCRIBED PREDNISONE.