BEUDAMED
    FDA Adverse Event Summary report: N

    LMA CLASSIC

    MDR report key: 3110804 · Received May 1, 2013

    Report

    Report Number
    3110804
    Date Received
    May 1, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 1, 2013
    Manufacturer
    LMA NORTH AMERICA, NOW PART OF TELEFLEX
    Product Code
    CAE
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LMA APERTURE BARS WERE INTENTIONALLY CUT FOR A BRONCHOSCOPY PROCEDURE. DURING THE PROCEDURE, A FOREIGN BODY WAS SEEN IN PT'S AIRWAY. CAREGIVERS ATTEMPTED TO REMOVE VIA SUCTION AND USING THE VIDEOSCOPE TO NO AVAIL. THEY GOT THE PIECE ABOVE THE VOCAL CHORDS BUT THEN COULD NOT FIND IT. THE ASSUMPTION IS THAT IT IS A PIECE OF APERTURE BAR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BRONCHOSCOPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190925 LMA CLASSIC AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY CAE LMA NORTH AMERICA, NOW PART OF TELEFLEX * *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR