BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTRA GENISYS

    MDR report key: 1002950 · Received February 5, 2008

    Report

    Report Number
    1022819-2008-00036
    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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN OF THE UNIT FOR EVALUATION.

    Description of Event or Problem · 1

    CLINICIAN WAS CONDUCTING A 7 MINUTE ULTRASOUND TREATMENT ON THE PLANTAR FASCITIS OF THE FOOT. THREE MINUTES INTO THE TREATMENT THE PT COMPLAINED OF A SHOCKING SENSATION AND A BURNING SENSATION FROM THE ULTRASOUND APPLICATOR. THE CLINICIAN WAS USING A 5CM SQUARED APPLICATOR, REPORTED TO BE IN GOOD CONDITION. THE TREATMENT SETTING WHERE TYPICAL TO PREVIOUS TREATMENTS, USING A 5CM SQUARE APPLICATOR OUTPUTTING .8 WATTS PER CM SQUARED, ON 3.3 MHZ AND A DUTY CYCLE OF 50%. THE CLINICIAN TERMINATED THE TREATMENT. THE PT SUFFERED NO BURNS TO THE TREATMENT AREA. THE CLINICIAN REPORTED THAT THE APPLICATOR HAD NO DISCOLORING ON THE HEAD SURFACE, WHICH IS TYPICAL TO BURNING AND/OR OVERHEATING. THE CLINICIAN TYPICALLY CONDUCTS TREATMENTS WITH THE APPLICATOR HEAD WARMING FEATURE TURNED OFF. THE CONDUCTOR USED FOR THE TREATMENT WAS A HYDROCORTISONE CREAM AND ULTRASOUND GEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS POWER MUSCLE STIMULATOR IPF CHATTANOOGA GROUP 2789

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other