BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARYNGEAL MASK AIRWAY

    MDR report key: 120716 · Received September 15, 1997

    Report

    Report Number
    2027158-1997-00031
    Event Type
    Injury
    Date Received
    September 15, 1997
    Date of Event
    August 25, 1997
    Report Date
    August 25, 1997
    Manufacturer
    THE LARYNGEAL MASK CO.
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A 21 YR OLD PT REGURGITATED WHILE AN LMA WAS BEING USED DURING AN INGUINAL HERNIA REPAIR. WHEN THE PT VOMITED, THE ANESTHESIOLOGIST LEFT THE LMA IN PLACE, SUCTIONED, AND ELEVATED THE HEAD. THE LMA WAS REMOVED AND THE PT WAS INTUBATED. A BRONCHOSCOPY CONFIRMED THAT THE PT DID NOT ASPIRATE. THE PT WAS OBSERVED FOR SEVERAL HRS IN THE PACU AND THEN SENT HOME. THE RPTR INQUIRED ABOUT THE RECOMMENDED PROCEDURES FOR MANAGING REGURGITATION WITH THE LMA PLACE. GENSIA'S SAFETY OFFICER DIRECTED THE RPTR TO THE SECTION IN THE LMA INSTRUCTION MANUAL WHICH DESCRIBES THE PROCEDURES TO BE FOLLOWED IN THIS SITUATION. THERE WAS NO REPORT OF A PROBLEM WITH THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARYNGEAL MASK AIRWAY OROPHARYNGEAL AIRWAY CAE THE LARYNGEAL MASK CO. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention