WEIGHT OF PATIENT IS UNKNOWN. ETHNICITY OF PATIENT IS UNKNOWN. RACE OF PATIENT IS UNKNOWN. NO KNOWN RELEVANT TESTS OR LABORATORY DATA. NO KNOWN RELEVANT HISTORY. HU-FRIEDY DOES NOT TRACK CLASS 1 DEVICES BY SERIAL NUMBER OR UDI, ONLY BY A LOT NUMBER, WHICH IS TIED TO THE DATE OF MANUFACTURE. THE PRODUCT INVOLVED IN THE EVENT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. PREPROCESSOR DOES NOT APPLY. NO CONCOMITANT MEDICAL PRODUCTS OR THERAPY DATES PROVIDED. IND DOES NOT APPLY.
D
Patient 1
IT WAS REPORTED TO HU-FRIEDY THAT A PATIENT WAS BEING TREATED WHEN THE TIP OF AN INSTRUMENT BROKE AND BECAME LODGED IN THE GUM NEAR THE MESIAL OF TOOTH #2.