BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LMA

    MDR report key: 874390 · Received June 28, 2007

    Report

    Report Number
    MW5002874
    Event Type
    Injury
    Date Received
    June 28, 2007
    Date of Event
    August 17, 2006
    Report Date
    June 19, 2007
    Manufacturer
    LMA NORTH AMERICA, INC.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANESTHESIOLOGIST REPORTS POSSIBLE COMPLICATION/ASPIRATION OF FOREIGN OBJECT COMING OFF REUSABLE LMA TUBES. WHILE INTUBATING PT'S, DOCTOR NOTICED WITH PT, PIECE OF BLUE RUBBER FROM TUBES INFLATION BALLOON INSIDE MIDDLE OF TUBE. DOCTOR NOTICED WITH PT, PIECE OF TAG/TAPE THAT CAME OFF TUBE HUB, INSIDE MIDDLE OF TUBE, WITH HUB OF TUBE COMING COMPLETELY APART. WITH BOTH PT'S DOCTOR HAD TO EXTUBATE AND RE-INTUBATE POSSIBLE ASPIRATION INTO LUNGS. WE NO LONGER USE RE-USABLE LMA'S ONLY BY DISPOSABLE.

    Description of Event or Problem · 2

    ANESTHESIOLOGIST REPORTS POSSIBLE COMPLICATION/ASPIRATION OF FOREIGN OBJECT COMING OFF REUSABLE LMA TUBES; WHILE INTUBATING PTS, DOCTOR NOTICED WITH PT, PIECE OF BLUE RUBBER FROM TUBES INFLATION BALLOON INSIDE MIDDLE OF TUBE. DOCTOR NOTICED WITH PT, PIECE OF TAG/TAPE THAT CAME OFF TUBE HUB, INSIDE MIDDLE OF TUBE, WITH HUB OF TUBE COMING COMPLETELY APART. WITH BOTH PTS DOCTOR HAD TO EXTUBATE AND RE-INTUBATE POSSIBLE ASPIRATION INTO LUNGS. WE NO LONGER USE RE-USABLE LMA'S ONLY BY DISPOSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LMA LARYNGEAL MASK AIRWAY CAE LMA NORTH AMERICA, INC. LMA CLASSIC

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| L
    2 YR Hospitalization| L