BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTRA GENISYS LASER

    MDR report key: 1012384 · Received March 7, 2008

    Report

    Report Number
    1022819-2008-00070
    Event Type
    Other
    Date Received
    March 7, 2008
    Date of Event
    February 13, 2008
    Report Date
    March 6, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN AND EVALUATION OF THE DEVICE.

    Description of Event or Problem · 1

    A PATIENT RECEIVING A LASER THERAPY HEAT TREATMENT RECEIVED BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS LASER HEAT THERAPY GEX CHATTANOOGA GROUP 2784

    Patients

    Seq Age Sex Outcome Treatment
    1 Other