BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTRA GENISYS

    MDR report key: 1010253 · Received March 11, 2008

    Report

    Report Number
    1022819-2008-00091
    Event Type
    Other
    Date Received
    March 11, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 10, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN, AND EVALUATION OF THE DEVICE.

    Description of Event or Problem · 1

    PT RECEIVED UNINTENDED OUTPUT DURING ELECTROTHERAPY TREATMENT.

    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 Other