BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VECTRA GENISYS 2CHG COMBO

    MDR report key: 1171155 · Received September 23, 2008

    Report

    Report Number
    1022819-2008-00247
    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 INFORMATION WILL BE PROVIDED VIA THE FORM 3500A, AS REQUIRED. REFERENCE REPORT: 1022819-2008-00360.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TREATED WITH ELECTROSURGERY FOR UPPER BACK PAIN. THE PATIENT RECEIVED A BURN IN THE AREA OF TREATMENT, UNDER THE ELECTRODES. THE PATIENT DID NOT REQUIRE OR SEEK MEDICAL CARE AS A RESULT OF THE BLISTER. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. THE PATIENT WAS BEING TREATED WITH THE ELECTROTHERAPY WAVEFORM IN THE AREA OF THE UPPER BACK AND SHOULDERS. THE CLINICIAN APPLIED THE TREATMENT AND INSTRUCTED THE PATIENT ON HOW TO ADJUST THE TREATMENT INTENSITY. THE PATIENT COMPLETED THE TREATMENT. LATER IN THE DAY, AFTER THE PATIENT LEFT THE CLINIC, THE PATIENT REPORTED THE APPEARANCE OF A SMALL BLISTER IN THE AREA OF ONE OF THE TREATMENT ELECTRODES. THE BURN WAS 2ND DEGREE AND MEASURED < 2 CM IN DIAMETER. THE CLINICIAN REPORTED THE PATIENT EXPRESSED MINOR DISCOMFORT DURING THE TREATMENT, BUT COMPLETED THE 15 MINUTE TREATMENT. THE TREATMENT ELECTRODES HAD LESS THAN 20 TREATMENT USES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention