BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA

    MDR report key: 982785 · Received November 28, 2007

    Report

    Report Number
    982785
    Event Type
    Malfunction
    Date Received
    November 28, 2007
    Date of Event
    November 16, 2007
    Report Date
    November 28, 2007
    Manufacturer
    LMA NORTH AMERICA, INC.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN PLACED THE LMA (LARYNGEAL MASK AIRWAY) IN THE PATIENT'S AIRWAY. THE PHYSICIAN NOTED SOMETHING IN THE LMA AND SUCTIONED IT OUT. IT WAS A CLEAR PLASTIC PIECE WITH NUMBERS ON IT. WHEN COMPARED TO ANOTHER LMA IT WAS NOTED THAT IS WAS A SERIAL NUMBER THAT IS NORMALLY AFFIXED TO THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR