BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND XT 2CH STIM PKG1 2770 STIM MODULE CH

    MDR report key: 2040957 · Received March 25, 2011

    Report

    Report Number
    9616086-2011-00035
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 25, 2011
    Manufacturer
    DJ ORTHOPEDICS DE MEXICO
    Product Code
    IMG
    PMA / PMN Number
    K031077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTS "UNIT IS SHOCKING AND BURNING THE PATIENTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND XT 2CH STIM PKG1 2770 STIM MODULE CH ELECTROTHERAPY IMG DJ ORTHOPEDICS DE MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other