BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNI GUIDE

    MDR report key: 1873794 · Received September 24, 2010

    Report

    Report Number
    MW5017726
    Event Type
    Death
    Date Received
    September 24, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 24, 2010
    Manufacturer
    OMNI GUIDE INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNEXPECTED PERIOPERATIVE MORTALITY (B)(6) FEMALE UNDERWENT ELECTIVE EXCISION LIP HEMANGIOMA. ASAII AT INITIATION OF PROCEDURE CO2 LASER APPLIED 5-10 SECONDS. IMMEDIATE SUBCUTANEOUS EMPHYSEMA NOTED - PROCEDURE DISCONTINUED IMMEDIATELY. PT VITAL SIGNS DETERIORATED - CARDIAC ARREST - DESPITE AGGRESSIVE RESUSITATION PT EXPIRED. CORONER'S CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI GUIDE CO2 LASER CLASS IV LASER GEX OMNI GUIDE INC LUMENIS 30 C

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death DNA