NON LATEX ELASTIC HY (H4) 3/16 BERN

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. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED. RETAIN PRODUCT WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

Description of Event or Problem

A PATIENT EXPERIENCED TINGLING, ITCHINESS, AND RED HIVES ON FACE AND TINGLING AND ITCHINESS INSIDE MOUTH AND TONGUE ON (B)(6) 2020. THE SYMPTOMS SUBSIDED WITHIN 1 HOUR. THE PATIENT WAS TAKEN TO AN EMERGENCY ROOM IN (B)(6) WHERE THE PATIENT WAS EXAMINED BUT NO TESTING WAS DONE DUE TO REACTION HAVING SUBSIDED PRIOR TO BEING TREATED AT THE ER. THE PATIENT'S PCP HAD ADVISED SOME TIME AGO THAT THE PATIENT WAS ALLERGIC TO LATEX AS THE PATIENT HAD A SIMILAR REACTION TO LATEX GLOVES THAT THE PATIENT'S PCP HAD USED DURING TREATMENT. THE PATIENT HAD NOT RECEIVED A FORMAL DIAGNOSIS BY TESTING. THE COMPLAINANT, IS A NURSE IN THE SCHOOL THAT THE PATIENT ATTENDS. THE COMPLAINANT STATED THAT THE PATIENT USING THE ELASTICS FOR BRACES AND THE ORTHODONTIST HAD PROVIDED THE PATIENT WITH DENTSPLY NON LATEX ELASTICS FOR APPROXIMATELY 6 MONTHS WITHOUT THE PATIENT EXPERIENCING ANY PROBLEMS AND USED THE LAST ELASTICS IN A PREVIOUS BAG ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT PUT THE ELASTICS IN THE MOUTH FROM A NEW BAG AND IMMEDIATELY EXPERIENCED THE ALLERGIC REACTION. THE PATIENT TOOK THE ELASTICS OUT OF THE MOUTH AND THE SYMPTOMS SUBSIDED WITHIN AN HOUR. THE COMPLAINANT AND THE PATIENT'S MOTHER BELIEVE THAT THERE IS LATEX IN THE NON LATEX ELASTICS THAT THE PATIENT HAD USED.