BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALIVA EJECTOR

    MDR report key: 719920 · Received July 26, 2005

    Report

    Report Number
    2411236-2005-14203
    Event Type
    Malfunction
    Date Received
    July 26, 2005
    Date of Event
    June 27, 2005
    Report Date
    July 25, 2005
    Manufacturer
    ASA DENTAL
    Product Code
    DYN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE SALIVA EJECTOR CAME OFF AND WAS SWALLOWED BY THE PT DURING A BRONCHOSCOPY PROCEDURE. THEY BEGAN TO WAKE THE PT UP WHEN THEY NOTICED THAT THE TIP WAS MISSING. THEY THEN STOPPED WAKING UP THE PT AND REINTRODUCED THE BRONCHOSCOPE. THE TIP OF THE SALIVA EJECTOR HAD ENTERED THE PT'S LUNG, BUT THE DOCTOR WAS ABLE TO RETRIEVE IT BY USING A SNARE. THE BRONCHOSCOPE WAS THEN REMOVED AND THE PT WAS AWAKENED. NO COMPLICATIONS WERE REPORTED. THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALIVA EJECTOR DENTAL SALIVA EJECTOR DYN ASA DENTAL NA C310 MAY O5 008800

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention