BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP PNCL W/HLSTR BULKPAK

    MDR report key: 1236703 · Received November 14, 2008

    Report

    Report Number
    1717344-2008-00546
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 7, 2008
    Report Date
    November 10, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED, BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE MEDWATCH REPORTED THAT WHILE USING GENERAL ANESTHESIA VIA MASK, APPROXIMATELY 1 MINUTE INTO THE PROCEDURE, FLAMES OCCURRED UNDER THE DRAPES AT RIGHT SIDE OF FACE WHILE USING CAUTERY. THIS RESULTED IN A 2ND DEGREE BURN TO THE PT'S FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP PNCL W/HLSTR BULKPAK ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) * 146503

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR