BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 7439870 · Received April 18, 2018

    Report

    Report Number
    2919128-2018-00009
    Event Type
    Injury
    Date Received
    April 18, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEWED STERILIZATION AND STERILE BARRIER INSPECTION RECORDS FOR LOT. NO PATTERN RELATED TO IRRADIATION DOSE OR DEVICE LOT WAS NOTED. CONFIRMED LABELING INCLUDED CAUTIONS REGARDING PIN SITE CARE.

    Description of Event or Problem · 0

    PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION DEVICE. WHEN HBL EMPLOYEE CALLED TO INQUIRE ABOUT THE PATIENT, THE PHYSICAL THERAPIST REPORTED THE PHYSICIAN REMOVED THE DEVICE BECAUSE OF A PIN TRACT INFECTION BUT THE JOINT WAS ALREADY STRAIGHT.

    Additional Manufacturer Narrative · 1

    REVIEWED STERILIZATION AND STERILE BARRIER INSPECTION RECORDS FOR LOT. NO PATTERN RELATED TO IRRADIATION DOSE 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 DEVICE. WHEN HBL EMPLOYEE CALLED TO INQUIRE ABOUT THE PATIENT, THE PHYSICAL THERAPIST REPORTED THE PHYSICIAN REMOVED THE DEVICE BECAUSE OF A PIN TRACT INFECTION BUT THE JOINT WAS ALREADY STRAIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284930 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB, INC. DWD-232 DWD-102-344

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention