BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 8095010 · Received November 21, 2018

    Report

    Report Number
    2919128-2018-00029
    Event Type
    Injury
    Date Received
    November 21, 2018
    Report Date
    November 23, 2018
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Product Code
    JDW
    UDI-DI
    00861994000212
    PMA / PMN Number
    K992970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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 THREE DIGIT WIDGET EXTERNAL FIXATION SYSTEMS. THE PHYSICIAN REPORTED THAT HE 'HAD TO PULL ONE OF THE PINS, THE PROXIMAL ONE' ON 1 OF THE 3 DEVICES BECAUSE 'IT WAS INFECTED'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935854 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB, INC. DWD-232 DWD-118-003 00861994000212

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention