BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 8203134 · Received December 28, 2018

    Report

    Report Number
    2919128-2018-00028
    Event Type
    Injury
    Date Received
    December 28, 2018
    Report Date
    December 28, 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

    USE OF THE WORD IMPINGEMENT IMPLIES THE DEVICE AFFECTED THE ADJACENT FINGERS THROUGH CONTACT. THE DIGIT WIDGET IS INSTALLED ON THE DORSAL ASPECT OF THE FINGER WITH NO PORTION EXTENDING TO THE RADIAL, ULNAR, OR PALMAR SIDES SO CONTACT SHOULD NOT BE POSSIBLE. IT IS UNCLEAR WHAT COULD HAVE ALLOWED THE DEVICE TO AFFECT THE ADJACENT FINGERS BASED ON THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    ARTICLE 'PRELIMINARY SOFT-TISSUE DISTRACTION VERSUS CHECKREIN LIGAMENT RELEASE AFTER FASCIECTOMY IN THE TREATMENT OF DUPUY REN PROXIMAL INTERPHALANGEAL JOINT CONTRACTURES' PUBLISHED PLASTIC AND RECONSTRUCTIVE SURGERY, VOL. 128, NO. 5, NOVEMBER 2011. ON PAGE 1111 IT WAS REPORTED THAT "ONE DIGIT WIDGET WAS REMOVED EARLY BECAUSE OF IMPINGEMENT ON AN ADJACENT DIGIT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043196 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB, INC. DWD-232

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention