BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARYNGEAL MASK AIRWAY

    MDR report key: 34077 · Received May 24, 1996

    Report

    Report Number
    2027158-1996-00004
    Event Type
    Injury
    Date Received
    May 24, 1996
    Date of Event
    April 1, 1996
    Report Date
    May 23, 1996
    Manufacturer
    GENSIA LABORATORIES, INC.
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ONE DAY AFTER THE PT UNDERWENT A THREE HR PROCEDURE DURING WHICH THE DEVICE WAS USED, THE PT COMPLAINED OF DIFFICULTY SPEAKING AND WAS COUGHING UP "MATERIAL." THE PT WAS REFERRED TO THE ER WHERE STEROIDS AND ANTIBIOTICS WERE ADMINISTERED. THE PT OUTCOME IS NOT KNOWN AT THIS TIME. SUBSEQUENT CONTACT WITH THE OR SUPV DETERMINED THAT AT THE TIME OF THE EVENT, THE DEVICES WERE BEING CLEANED WITH AMERSE, A PHENOL BASED SOAP, CONTRARY TO THE PRODUCT LABELLING. THE SITE REPORTED THEY DISCONTINUED USE OF THIS PRODUCT AFTER A CO'S REP NOTIFIED THEM THAT THE LABELLING WARNING AGAINST USE OF SUCH CLEANING AGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARYNGEAL MASK AIRWAY OROPHARYNGEAL AIRWAY CAE GENSIA LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention