BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENISYS 4CH COMBO

    MDR report key: 2190894 · Received July 28, 2011

    Report

    Report Number
    9616086-2011-00092
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 28, 2011
    Manufacturer
    DJO GLOBAL
    Product Code
    ILY
    PMA / PMN Number
    K040662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BIOMED CALLED TO SAY UNIT BURNED PATIENT DURING STIM. UNIT AND ACCESSORIES PASSED INSPECTION. NO PROBLEMS WERE DUPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENISYS 4CH COMBO ELECTROTHERAPY ILY DJO GLOBAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other