BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VECTRA GENISYS 2CH COMBO

    MDR report key: 2893438 · Received September 23, 2008

    Report

    Report Number
    1022819-2008-00360
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 1, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IMG
    PMA / PMN Number
    K031077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, NO ROOT CAUSE CAN BE DETERMINED. ADDITIONAL INFO WILL BE PROVIDED VIA THE FORM 3500A, IF REQUIRED. REFERENCE REPORT: 1022819-2008-00247.

    Description of Event or Problem · 1

    THE PT WAS BEING TREATED WITH ELECTROTHERAPY STIMULATION WHEN THEY SUFFERED A BURN IN THE AREA OF THE TREATMENT UNDER THE APPLICATION ELECTRODES. THE AREA OF TREATMENT WAS NOT PROVIDED. THE CLINICIAN APPLIED THE TREATMENT AND INSTRUCTED THE PT ON HOW TO ADJUST THE TREATMENT INTENSITY. THE PT COMPLETED THE TREATMENT. UPON REMOVAL OF THE TREATMENT ELECTRODES, THE CLINICIAN NOTED A BURN UNDER ONE OF THE TREATMENT ELECTRODES. THE DEGREE AND SIZE OF THE BURN IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS 2CH COMBO IMG; GZI, GZJ, HCC, IPF IMG CHATTANOOGA GROUP 2761

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention