BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTRA GENISIS

    MDR report key: 1016330 · Received March 21, 2008

    Report

    Report Number
    1022819-2008-00102
    Event Type
    Other
    Date Received
    March 21, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 20, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING DEVICE RETURNED AND EVALUATION. TYPE OF DEVICE: IPF, STIMULATOR, MUSCLE, POWERED, 890.5858; GZI, STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL 882.5810; HCC, DEVICE, BIOFEEDBACK, 882.5050; IMG, STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT, 890.5860.

    Description of Event or Problem · 1

    PATIENT RECEIVED A BURN DURING AN ELECTROTHERAPY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISIS GZJ, STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF, 882.5810 GZJ CHATTANOOGA GROUP 2789

    Patients

    Seq Age Sex Outcome Treatment
    1 Other