BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTRA GENISYS

    MDR report key: 1060937 · Received June 11, 2008

    Report

    Report Number
    1022819-2008-00169
    Event Type
    Other
    Date Received
    June 11, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 29, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING DEVICE RETURN AND EVAL.

    Description of Event or Problem · 1

    PT RECEIVED A SKIN BURN DURING TREATMENT WITH THE DEVICE.

    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