BIOFORM IPN PLASTIC TEETH (20° POSTERIORS)

Additional Manufacturer Narrative

THE PATIENT HAS DECLINED TO RETURN THE SAMPLE FOR INVESTIGATION AT THIS TIME. 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

IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION WITH SYMPTOMS INCLUDING SWELLING OF THE TONGUE ONE HOUR AFTER INSERTION OF A REMOVABLE LOWER PARTIAL DENTURE FABRICATED WITH BIOFORM IPN TEETH AND VALPLAST RESIN (COMPETITIVE PRODUCT). THE PATIENT WAS TREATED FOR SYMPTOMS IN THE ER AND SYMPTOMS ALLEVIATED ONCE THE DEVICE WAS REMOVED FROM THE MOUTH FOR 24 HOURS.