VANISH 5% SODIUM FLUORIDE WHITE VARNISH

Additional Manufacturer Narrative

CUSTOMER WAS UNABLE TO SPECIFICALLY IDENTIFY WHICH LOT WAS USED ON PATIENT, BUT BASED ON SALES INFORMATION, IT'S LIKELY THAT ONE OF TWO LOTS WERE INVOLVED. SECOND LOT NUMBER :11706. D4: 2ND LOT: EXPIRATION DATE: 07/31/2007. 2ND LOT: DEVICE MFR DATE: 01/2007. ANALYTICAL TESTING WAS CONDUCTED ON BOTH LOTS OF PRODUCT THAT WAS POSSIBLY USED ON THE PATIENT; THESE ANALYTICAL TESTS SHOW THAT THE PRODUCT POSSIBLY USED IN THE PATIENT IS NOT CHEMICALLY DIFFERENT FROM COMPARATIVE REFERENCE LOTS OF PRODUCT. BASED ON THE PRODUCT'S BIOCOMPATIBILITY ASSESSMENT, VANISH VARNISH IS SAFE FOR IT'S INTENDED USE AND REACTIONS SUCH AS THIS ARE NOT ANTICIPATED.

Description of Event or Problem

FEMALE PATIENT HAD VANISH APPLIED IN 2007. PATIENT ALLEGEDLY EXPERIENCED SWELLING OF HER THROAT, DIFFICULTY IN BREATHING AND DEVELOPED A RASH AROUND HER MOUTH AND EAR. THE PATIENT REPORTEDLY WENT TO THE ER THE EVENING OF THE SAME DAY. DETAILS OF THE TREATMENT PROVIDED AT THE ER ARE NOT AVAILABLE TO 3M ESPE. ON THE FOLLOWING MONTH, THE PATIENT REPORTED THE EVENT TO THE DENTAL OFFICE. THE PATIENT HAS SINCE BEEN BACK TO HER PHYSICIAN, AND HE HAS RECOMMENDED PATIENT TO BE ALLERGY TESTED.