BEUDAMED
    FDA Adverse Event Summary report: N

    HU-FRIEDY MFG. CO., LLC

    MDR report key: 6178528 · Received December 15, 2016

    Report

    Report Number
    1416605-2016-00008
    Date Received
    December 15, 2016
    Report Date
    December 15, 2016
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    DYX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    A PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER HER CHEEKBONE WAS STABILIZED WITH 25 GAUGE STAINLESS STEEL WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826881 HU-FRIEDY MFG. CO., LLC LIGATURE WIRE DYX HU-FRIEDY MFG. CO., LLC WPLW25

    Patients

    Seq Age Sex Outcome Treatment
    1 Other