BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTRA GENISYS

    MDR report key: 1002951 · Received February 5, 2008

    Report

    Report Number
    1022819-2008-00035
    Event Type
    Other
    Date Received
    February 5, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 31, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING DELIVERY OF DEVICE FOR EVALUATION.

    Description of Event or Problem · 1

    CLINICIAN WAS SETTING UP A HIVOLT ELECTROTHERAPY TREATMENT IN COMBINATION WITH ULTRASOUND. THE HIVOLT ELECTROTHERAPY TREATMENT WAS BEING DELIVERED USING 2.75 CM SELF ADHESIVE ELECTRODES AND THE ULTRASOUND TREATMENT WAS BEING DELIVERED USING THE 5CM SQUARE APPLICATOR. THE CLINICIAN INDICATED THAT THE ELECTROTHERAPY HIVOLT SETTING WAS 40 OR 50V. THE ULTRASOUND SETTING WAS 1.2W CM SQUARE AND ON CONTINUOUS DUTY CYCLE. THE ELECTRODES ARE DURA STICK BRAND ELECTRODES. THE CLINICIAN INDICATED THAT THE ELECTRODES WERE USED ELECTRODES. THE CLINICIAN WAS USING ULTRASOUND GEL. THE GEL WAS CLEAR OF ANY ELECTRODES BY AT LEAST 2". THE CLINICIAN WAS APPLYING ULTRASOUND, AT THE BEGINNING OF THE TREATMENT. IN APPLYING ULTRASOUND, THE CLINICIAN PROCEEDED TO START THE ELECTROTHERAPY TREATMENT. AS THE HIVOLT INTENSITY WAS SLIGHTLY INCREASED, THE PT IMMEDIATELY COMPLAINED OF PAIN. THE CLINICIAN TERMINATED THE TREATMENT AND REMOVED THE ELECTRODES TO EXAMINE THE SKIN. UPON EXAMINATION OF THE SKIN THE CLINICIAN NOTED A BURN LEVEL OF THE SKIN EQUAL TO THAT OF A LIGHT PINK DISCOLORING OF THE SKIN. THE PT DID NOT REQUIRE ADD'L MEDICAL CARE FOR THE PINK DISCOLORING OF THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS POWER MUSCLE STIMULATOR IPF CHATTANOOGA GROUP 2761

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other