HU-FRIEDY #11/12R CURETTE RIGID

Additional Manufacturer Narrative

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.

Description of Event or Problem

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.