BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARYNGEAL MASK AIRWAY

    MDR report key: 99986 · Received June 20, 1997

    Report

    Report Number
    2027158-1997-00019
    Event Type
    Malfunction
    Date Received
    June 20, 1997
    Report Date
    June 20, 1997
    Manufacturer
    THE LARYNGEAL MASK CO.,LTD.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN AIRWAY TUBE BROKE WHILE AN LMA WAS BEING USED IN A PT. THERE WAS NO REPORT OF SERIOUS INJURY OR ANY RISK TO THE PT. CO IS TRYING TO OBTAIN FURTHER INFO REGARDING THE EVENT FROM THE ATTENDING PHYSICIAN. AN MDR IS BEING FILED, EVEN THOUGH THERE HAVE BEEN NO REPORTS OF PT INJURY ASSOCIATED WITH FAILED AIRWAY TUBES, AS THEORETICALLY A BROKEN AIRWAY TUBE COULD CAUSE INJURY TO A PT. THE USER FACILITY HAS BEEN REQUESTED TO RETURN THE LMA TO THE MFR FOR EVAL. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE LMA HAS BEEN RETURNED AND EVALUATED. THIS REPORT CONTAINS INFO FROM THIRD PARTY SOURCES, THE ACCURACY OF WHICH HAS NOT BEEN CONFIRMED BY THE REPORTER. NEITHER THE SUBMISSION OF THIS REPORT, NOR ITS RELEASE BY FDA, CONSTITUTES AN ADMISSION THAT THE MFR, DISTRIBUTOR, DEVICE OR REPORTING PARTY CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARYNGEAL MASK AIRWAY OROPHARYNEAL AIRWAY CAE THE LARYNGEAL MASK CO.,LTD. STANDARD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN