BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 8120254 · Received November 30, 2018

    Report

    Report Number
    2919128-2018-00030
    Event Type
    Injury
    Date Received
    November 30, 2018
    Report Date
    November 30, 2018
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Product Code
    JDW
    PMA / PMN Number
    K992970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYZED PRODUCTION RECORDS, PERFORMED HISTORICAL DATA ANALYSIS AND TREND ANALYSIS. NO TREND RELATED TO IRRADIATION DOSE LOT OR POSSIBLE DEVICE LOST WERE 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 OCCUPATIONAL THERAPIST REPORTED THAT PATIENT PRESENTED WITH INFECTION AT 3 WEEKS. ANTIBIOTICS WERE PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959736 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB, INC. DWD-232

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention