BEUDAMED
    FDA Adverse Event Other Summary report: N

    LARYNGEAL SEAL AIRWAY

    MDR report key: 217391 · Received April 2, 1999

    Report

    Report Number
    2183725-1999-00002
    Event Type
    Other
    Date Received
    April 2, 1999
    Date of Event
    March 5, 1999
    Report Date
    March 30, 1999
    Manufacturer
    AUGUSTINE MEDICAL, INC.
    Product Code
    CAE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSERTION OF THE LARYNGEAL SEAL AIRWAY, PERFORMED DURING TRAINING, CAUSED A POSTERIOR PHARYNGEAL LACERATION. MINOR BLEEDING OCCURRED WHICH SPONTANEOUSLY ENDED WITHOUT INTERVENTION. PT FULLY RECOVERED WITH NO PERMANENT IMPAIRMENT OR DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARYNGEAL SEAL AIRWAY OROPHARYNGEAL AIRWAY CAE AUGUSTINE MEDICAL, INC. LSA BY-M

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| O