INTEGRITY TEMPGRIP

Additional Manufacturer Narrative

MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. RETAINED PRODUCT WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

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

IT WAS REPORTED THAT A PATIENT EXPERIENCED A RASH AFTER THE USE OF INTEGRITY TEMPGRIP. THE DENTIST REPORTED THAT THEY HAD USED INTEGRITY TEMPGRIP IN THE PAST ON THIS PATIENT, AND THERE WAS NEVER ANY REACTION. THE PATIENT IS A THROAT CANCER SURVIVOR AND IS CURRENTLY GETTING INJECTIONS FOR SALIVA PRODUCTION AND IS ALSO USING CHLOROHEXIDINE RINSE. THE DENTIST ALSO REPORTED THAT THIS PATIENT IS PRONE TO THRUSH AND THAT THEIR NIGHTGUARD WAS VERY DIRTY AND CAUSING THE PATIENT TO HAVE ISSUES. THE PATIENT CONTINUED WITH THE RINSE AND THE RASH IS MOSTLY GONE.