INTEGRITY TEMPGRIP
Received Jul 23, 2015
Report 2515379-2015-00047 · MDR key 4943404
Device
Product problems
- Patient-Device Incompatibility
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Swelling
- Reaction
Narrative
Additional Manufacturer Narrative
MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PT OUTCOME. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. 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 AN UNKNOWN NUMBER OF PATIENTS EXPERIENCED SWOLLEN LIPS AFTER USE OF INTEGRITY TEMP GRIP CEMENT. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT YET AVAILABLE.
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.