BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARYNGEAL MASK AIRWAY

    MDR report key: 111559 · Received August 7, 1997

    Report

    Report Number
    9681900-1997-00026
    Event Type
    Injury
    Date Received
    August 7, 1997
    Date of Event
    July 1, 1997
    Report Date
    July 23, 1997
    Manufacturer
    THE LARYNGEAL MASK CO.,LTD.
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPRESENTATIVE OF GENSIA WAS INFORMED OF AN ADVERSE EVENT THAT OCCURRED AFTER LMA USE. THE CASE INVOLVED A FEMALE PT WHO UNDERWNET A 1.5 HOUR CYSTOSCOPY AND EXPLORATION. DURING RECOVERY, THE PT INITIALLY COMPLAINED OF A SCRATCHY THROAT. THIS DEVELOPED INTO RESPIRATORY COMPLAINTS. A FIBEROPTIC EXAM REVEALED THE PT'S ARYTENOIDS WERE VERY EDEMATOUS AND PARTIALLY OCCLUDING THE AIRWAY. THE PT WAS INTUBATED, GIVEN MULTIPLE DOSES OF IV DECADRON, AND VENTILATED IN THE ICU FOR TWO DAYS. THE PT WAS EXTUBTED AFTER 48 HOURS, AND HAS SUBSEQUENTLY BEEN DISCHARGED. THE ENT CONSULTANT THOUGHT THE PT'S SYMPTOMS WERE CONSISTENT WITH AN ALLERGIC RESPONSE.

    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 44 YR Hospitalization