HU-FRIEDY MFG. CO., LLC
Received Dec 15, 2016
Report 1416605-2016-00008 · MDR key 6178528
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Reaction
- Reaction
Narrative
Additional Manufacturer Narrative
HU-FRIEDY DOES NOT TRACK OUR DEVICES (WHICH ARE MOSTLY LOW RISK 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. REPROCESSOR DOES NOT APPLY NO CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES PROVIDED. PMA/510(K) IS NOT APPLICABLE. IND IS NOT APPLICABLE.
Description of Event or Problem
A PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER HER CHEEKBONE WAS STABILIZED WITH 25 GAUGE STAINLESS STEEL WIRE.