UNK PREV - LDP IPN SHADE A3

Additional Manufacturer Narrative

INVESTIGATION RESULTS: AN ALLERGIC REACTION IS A KNOWN RESIDUAL RISK FOR LUCITONE DIGITAL PRINT. IT CAN BE FOUND IN THE RISK ASSESSMENT TABLE, 0060-RISK-RA-0160 IN LINES 1-2, 5, 84, 91, 95, 100, AND 185. THIS RISK HAS BEEN REDUCED AS FAR AS POSSIBLE. FAILURE MODE: SERIOUS ADVERSE REACTION. ROOT CAUSE: OTHER. ROOT CAUSE CATEGORY: MATERIAL. CONCLUSION CODE: EXPECTED UNDESIRABLE SIDE EFFECTS.

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 WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

Description of Event or Problem

WHILE THE CUSTOMER WAS USING LDP IPN SHADE A3, THEY ALLEGE THAT, THE PATIENT SAID, WHEN SHE HAD HER NEW DENTURE IN HER MOUTH THE MARGIN OF HER TONGUE IS TINGLY, ALL-AROUND INCLUDING TIP AND THE BACK. THIS COULD BE POSSIBLE ALLERGIC REACTION. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.