BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 14686009 · Received June 14, 2022

    Report

    Report Number
    2919128-2022-00004
    Event Type
    Injury
    Date Received
    June 14, 2022
    Report Date
    June 14, 2022
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Product Code
    JDW
    UDI-DI
    00861994000212
    PMA / PMN Number
    K992970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYZED PRODUCTION RECORDS, PERFORMED HISTORICAL DATA ANALYSIS AND TREND ANALYSIS. NO TREND RELATED TO IRRADIATION DOSE LOT OR DEVICE LOT WAS NOTED. CONFIRMED LABELING INCLUDED CAUTIONS REGARDING PIN SITE CARE.

    Description of Event or Problem · 0

    PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. SURGEON REPORTED "TREATED W ABX BUT ULTIMATELY THE PINS HAD TO BE REMOVED (WE TRIED TO SUPPRESS FOR A FEW WEEKS). PATIENT KEPT GETTING PURULENCE FROM THE WOUND." REMOVED THE DEVICE ATER "4 WEEKS OR SO" PRIOR TO COMPLETION OF CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879736 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB, INC. DWD-232 DWD-119-130B 00861994000212

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention