AVA GEL REFILL 410 GR

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. RETAIN THE MATERIAL HAS BEEN DULY TESTED AND IS IN COMPLIANCE WITH THE ESTABLISHED STANDARDS. DHR THE DHR OF THE MATERIAL IS EVALUATED, WHICH SHOWS THAT THE MATERIAL WAS PRODUCED AND RELEASED IN COMPLIANCE. OTHER: EVALUATED THE 1100-PIR-RA 0003 [1]: ¿TABELA DE AVALIAÇÃO DE RISCO - ALGINATOS¿, DOCUMENT THAT PROVIDES FOR THIS TYPE OF EVENT AND THE APPROPRIATE MITIGATIONS. IN ADDITION, 1100-PIR-DFU 0083 [2]: ¿IFU AVAGEL¿AND 1100-PIR-PKG-DS-AL-BN 0002 [3]: ¿2000000073 - 05.71.057-0000 BN AVAGEL 410G RTLC¿ DOCUMENTS WERE CHECKED, WHICH CONTAIN INFORMATION THAT THE PRODUCT MAY CAUSE AN ALLERGIC REACTION.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE AVA GEL REFILL 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.