CALIBRA VEN TRY-IN 1.8GM MD RF

Additional Manufacturer Narrative

INVESTIGATION: PRODUCT WAS EXPIRED FIVE YEARS AGO. NOT ABLE TO INVESTIGATE. PRODUCT EXPIRED IN 2018. COMPLAINT WAS SUBMITTED IN 2023. NO DEFECT PROVEN.

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

IN THIS EVENT IT IS REPORTED THAT CALIBRA VEN TRY-IN 1.8GM LT RF THAT WAS USED ALLEGEDLY CAUSED A IRRIATIATION REACTION TO A PATIENT. NO INJURY REPORTED. FURTHER INFORMATION REQUESTED.