BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARYNGEAL MASK AIRWAY

    MDR report key: 95225 · Received May 30, 1997

    Report

    Report Number
    2027158-1997-00013
    Event Type
    Malfunction
    Date Received
    May 30, 1997
    Date of Event
    May 1, 1997
    Report Date
    May 20, 1997
    Manufacturer
    THE LARYNGEAL MASK CO.,LTD.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THE CONNECTOR BROKE ON AN LMA WHEN IT WAS DISCONNECTED FROM THE CIRCUIT. ALTHOUGH THERE WAS NO PT INJURY, AN MDR IS BEING FILED AS FAILED CONNECTORS COULD THEORETICALLY CAUSE INJURY TO A PT. THE USER FACILITY HAS BEEN REQUESTED TO RETURN THE DEVICE IN QUESTION. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER THE LMA HAS BEEN RETURNED TO THE MFR AND EVALUATED. THIS REPORT CONTAINS INFO FROM THIRD PARTY SOURCES, THE ACCURACY OF WHICH HAS NOT BEEN CONFIRMED BY THE REPORTER. NEITHER 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 OROPHARYNGEAL AIRWAY CAE THE LARYNGEAL MASK CO.,LTD. STANDARD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN