BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 10252790 · Received July 9, 2020

    Report

    Report Number
    2919128-2020-00008
    Event Type
    Injury
    Date Received
    July 9, 2020
    Report Date
    July 10, 2020
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Product Code
    JDW
    UDI-DI
    00861994000212
    PMA / PMN Number
    K992970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. THE PATIENT REPORTED THAT 8 DAYS POST OPERATIVE HE VISITED AN EMERGENCY ROOM FOR PAIN AND SWELLING WHERE HE WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717242 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB, INC. DWD-232 DWD-119-145A 00861994000212

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention