BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTELECT LEGEND XT 4 CH COMBO

    MDR report key: 2417644 · Received January 11, 2012

    Report

    Report Number
    9616086-2012-00004
    Event Type
    Other
    Date Received
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    DJO, LLC
    Product Code
    GZI
    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

    PT RECEIVED BURNS DURING PREMOD TREATMENT AND NEEDED MEDICAL ATTENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other