BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIR CUSHION MASK W/VALVE, LARGE ADULT

    MDR report key: 1272412 · Received December 10, 2008

    Report

    Report Number
    1044475-2008-00046
    Event Type
    Other
    Date Received
    December 10, 2008
    Date of Event
    October 7, 2008
    Report Date
    November 25, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE NOT REC'D AT TIME OF THIS REPORT. INVESTIGATION RESULTS NOT AVAILABLE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED VIA A MEDWATCH ON 11/25/2008. THE EVENT IS REPORTED AS: USING GENERAL ANESTHESIA VIA MASK, ABOUT ONE MINUTE INTO PROCEDURE THERE WERE FLAMES UNDER DRAPES AT RIGHT SIDE OF FACE WHILE USING CAUTERY. THIS CAUSED SECOND DEGREE BURN TO PT'S FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR CUSHION MASK W/VALVE, LARGE ADULT SURE SEAL OXYGEN MASK BYG TELEFLEX MEDICAL NA 080417

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other