RECIPROC BLUE GUTTA-PERCHA POINTS - ASSORTMENT - BOX OF 60

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT A PATIENT HAS ALLEGEDLY EXPERIENCED AN ALLERGIC REACTION AFTER RECIPROC BLUE GUTTA-PERCHA POINTS - ASSORTMENT - BOX OF 60 WAS USED IN TREATMENT. THE PATIENT DEVELOPED PUSTULES ALL OVER THEIR BODY ABOUT 40 HOURS AFTER THE ROOT FILLING TREATMENT. PATIENT WAS SEEN BY A DERMATOLOGIST WHO WANTED TO DO A BIOPSY. PATIENT WAS GIVEN SOME MEDICATION BUT COULD NOT SAY WHAT MEDICATION. FURTHER INFORMATION REQUESTED.

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.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: DHR NOTHING UNUSUAL WAS FOUND DURING DHR REVIEW FOR LOT# 0000315939. DHR IS DATED 11/24/2021. 200 PACKS WERE MANUFACTURED: PRODUCTION SKU# GPMC0006-AST, PRODUCTION LOT# 2F21051906, EXP DATE 05/18/2025. QUERY INDICATES NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT NUMBER. OTHER PRODUCT WILL NOT BE RETURNED. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT HAS DECIDED TO CANCEL HIS APPOINTMENT WITH THE ALLERGIST BECAUSE THINGS HAVE GOTTEN MUCH BETTER. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION.