BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARYNGEAL MASK AIRWAY

    MDR report key: 312295 · Received January 12, 2001

    Report

    Report Number
    9681900-2001-00002
    Event Type
    Injury
    Date Received
    January 12, 2001
    Date of Event
    January 1, 2000
    Report Date
    December 12, 2000
    Manufacturer
    THE LARYNGEAL MASK CO
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AN ARTICLE WAS EVALUATED AND DISPOSITIONED BY LMA NORTH AMERICA MEDICAL AFFAIRS DEPT. THIS CASE INVOLVED A PT IN FRANCE WHO HAD AN UNEVENTFUL SURGERY FOR A CUTANEOUS NEVUS. IN THE RECOVERY ROOM, THE PT BIT DOWN ON THE LMA TUBE AND MADE FORCEFUL INSPIRATORY EFFORTS. OXYGEN SATURATION DECREASED TO 50% BEFORE THE LMA COULD BE REMOVED. THE OXYGEN SATURATION ROSE TO 98%; HOWEVER, 5 MINUTES LATER, THE PT DEVELOPED DYSPNEA AND HEMOPTYSIS. RALES WERE HEARD BILATERALLY, AND A CHEST X-RAY SHOWED EVIDENCE OF BILATERAL PULMONARY EDEMA. ARTERIAL BLOOD GAS SHOWED OXYGEN LEVEL OF 59 MM HG WITH 89% SATURATION. FIBEROPTIC BRONCHOSCOPY SHOWED DIFFUSE BILATERAL PINK FROTHY EDEMA FLUID. THE PT WAS TREATED IN THE ICU WITH NASAL OXYGEN ONLY. PT WAS DISCHARGED FROM THE ICU AFTER 24 HOURS WITH NORMAL PHYSICAL EXAM, BLOOD GASES, AND CHEST X-RAY. THE PT HAD NEGATIVE PRESSURE PULMONARY EDEMA CAUSED BY ACUTE AIRWAY OBSTRUCTION AFTER BITING DOWN ON THE LMA TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337 LARYNGEAL MASK AIRWAY OROPHARYNGEAL AIRWAY CAE THE LARYNGEAL MASK CO UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention