BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA NORTH AMERICA LMA - CLASSIC

    MDR report key: 222130 · Received May 5, 1999

    Report

    Report Number
    MW1016253
    Event Type
    Malfunction
    Date Received
    May 5, 1999
    Date of Event
    March 26, 1999
    Report Date
    April 27, 1999
    Manufacturer
    LMA NORTH AMERICA, INC.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SIZE 4 LMA WAS INSERTED APPARENTLY UNEVENTFULLY. FOLLOWING PLACEMENT, SLIGHT AMOUNT OF BLOOD NOTED EXTERIOR TO TUBE IN ORAL MUCOSA. WHILE ATTEMPTING TO REMOVE DIGITALLY, THE LMA TUBE BROKE NEAR THE MASK. FORCEP WERE THEN USED TO REMOVE THE MASK. PT ONLY OBSERVED WITH SMALL ABRASION ABOUT 1MM ON THE MUCOSA OF THE SOFT PALATE WITHOUT SIGNIFICANT OR LASTING INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other