BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L300 GO

    MDR report key: 7052417 · Received November 22, 2017

    Report

    Report Number
    MW5073521
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    November 15, 2017
    Report Date
    November 18, 2017
    Manufacturer
    BIONESS
    Product Code
    GZI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BRACE BURNED SKIN. CAUSING PAIN AND DIFFICULTY WALKING WITH ALREADY HAVING DIFFICULTIES HENCE THE NEED FOR THE BRACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833699 L300 GO STIMULATOR, NEUROMUSCULAR, EXTERNAL GZI BIONESS

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention