BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND XT 4CH COMBO PKG

    MDR report key: 2503073 · Received March 21, 2012

    Report

    Report Number
    9616086-2012-00017
    Event Type
    Injury
    Date Received
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    DJO, LLC
    Product Code
    GZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT SUFFERED A BURN ON THE FOREARM FROM AN ELECTRODE DURING ELECTROTHERAPY TREATMENT. THE PATIENT SOUGHT AND RECEIVED ADDITIONAL TREATMENT FROM A MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND XT 4CH COMBO PKG ELECTROTHERAPY - CLINIC GZI DJO, LLC 2788

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other