BEUDAMED
    FDA Adverse Event Death Summary report: N

    SALIVA EJECTOR

    MDR report key: 23622 · Received July 5, 1995

    Report

    Report Number
    23622
    Event Type
    Death
    Date Received
    July 5, 1995
    Date of Event
    June 25, 1995
    Report Date
    July 3, 1995
    Manufacturer
    T & S DENTAL & PLASTICS CO., INC.
    Product Code
    DYN
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 6/16/95, THIS PT RECEIVED A TRACHEOSTOMY FOR VENTILATORY DEPENDENCE AND CHRONIC-ASPIRATION. AFTER THE SURGERY, THE NURSES WERE USING THE SALIVA EJECTOR TO SUCTION SECRETIONS AROUND THE TRACHEOSTOMY. ON 6/25/95, THE PT WAS FOUND IN FULL CARDIAC ARREST. AT THE BEGINNING OF THE CODE, IT WAS NOTED THAT THE SALIVA EJECTOR WAS STUCK INSIDE THE OPENING OF THE TRACHEOSTOMY AND WAS COMPLETELY OCCLUDING THE AIRWAY. THE PT EXPIRED AT 0056 ON 6/25/95. IT APPEARED TO THE UNTRAINED EYE THAT THE EJECTOR BELONGED IN THE TRACHEOSTOMY DUE TO IT'S DESIGN, COLOR AND FIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALIVA EJECTOR DENTAL SUCTION DYN T & S DENTAL & PLASTICS CO., INC. 58

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death