BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARYNGEAL MASK AIRWAY

    MDR report key: 94853 · Received May 30, 1997

    Report

    Report Number
    9681900-1997-00015
    Event Type
    Injury
    Date Received
    May 30, 1997
    Report Date
    May 30, 1997
    Manufacturer
    THE LARYNGEAL MASK CO.,LTD.
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A 38 YEAR OLD FEMALE UNDERWENT LAPAROSCOPY FOR PELVIC INFLAMMATORY DISEASE. POSTOPERATIVELY, THE PT EXPERIENCED A SEVERE SORE THROAT AND HAD DIFFICULTY SWALLOWING. LOCAL ERYTHEMA WAS NOTED, AND THE PT WAS TREATED WITH STEROIDS. THE PT'S SYMPTOMS RESOLVED IN ABOUT TWO WEEKS. THE USER FACILITY SUSPECTS THE MASK INVOLVED IN THIS CASE WAS EXPOSED TO A PHENOL-BASED CLEANER, CONTRARY TO THE PRODUCT LABELING WHICH WARNS AGAINST SUCH CLEANERS, AND HAS TAKEN IT OUT OF SERVICE. THE ADVERSE EFFECTS SECTION OF THE LABELING STATES THAT A SERVICE OR PROLONGED SORE THROAT HAS BEEN REPORTED IN PTS IN WHOM AN IMPROPERLY CLEANED OR STERILIZED MASK HAS BEEN USED. THIS REPORT CONTAINS INFO FROM THIRD PARTY SOURCES, THE ACCURACY OF WHICH HAS NOT BEEN CONFIRMED BY THE REPORTER. NEITHER THE SUBMISSION OF THIS REPORT, NOR ITS RELEASE BY FDA, CONSTITUTES AN ADMISSION THAT THE MFR, DISTRIBUTOR, 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. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention