BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELECT TERANSPORT 2C STIM

    MDR report key: 2190881 · Received July 28, 2011

    Report

    Report Number
    9616086-2011-00091
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 28, 2011
    Manufacturer
    DJO GLOBAL
    Product Code
    IMG
    PMA / PMN Number
    K040285
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED FOUR PATIENTS BURNED USING IFU STIM. REQUESTED CUSTOMER RETURN UNIT, LEADWIRES, AND ELECTRODES FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT TERANSPORT 2C STIM ELECTROTHERAPY IMG DJO GLOBAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other