BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIGUIDE

    MDR report key: 2588369 · Received May 18, 2012

    Report

    Report Number
    MW5025475
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Date of Event
    April 12, 2012
    Report Date
    May 18, 2012
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OMNIGUIDE BEAMPATH FIBER PRODUCT USED WITH CO2 LASER FAILED AFTER 75 SECONDS OF USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIGUIDE BEAMPATH FIBER GEX OMNIGUIDE, INC. NEURO-L LA12323BM-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR