BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 8055444 · Received November 9, 2018

    Report

    Report Number
    2919128-2018-00026
    Event Type
    Injury
    Date Received
    November 9, 2018
    Report Date
    November 9, 2018
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Product Code
    JDW
    PMA / PMN Number
    K992970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    ARTICLE 'PRELIMINARY SOFT-TISSUE DISTRACTION VERSUS CHECKREIN LIGAMENT RELEASE AFTER FASCIECTOMY IN THE TREATMENT OF DUPUYREN PROXIMAL INTERPHALANGEAL JOINT CONTRACTURES' PUBLISHED PLASTIC AND RECONSTRUCTIVE SURGERY, VOL. 128, NO. 5, (B)(6) 2011. ON PAGE 1111 IT WAS REPORTED THAT "TWO-PIN TRACK INFECTIONS WERE TREATED WITH ANTIBIOTICS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894281 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB, INC. DWD-232

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention