BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOOTHETTE

    MDR report key: 1422069 · Received July 23, 2009

    Report

    Report Number
    1422069
    Event Type
    Malfunction
    Date Received
    July 23, 2009
    Date of Event
    July 8, 2009
    Report Date
    July 23, 2009
    Manufacturer
    SAGE PRODUCTS INC.
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    WHILE DOING ORAL CARE, THE SPONGE CAME OFF THE TOOTHETTE IN THE PATIENT'S MOUTH. IT TRAVELED DOWN INTO THE PT'S THROAT. THE NURSE PRACTITIONER USED A GLIDASCOPE AND MAGILL FORCEPS TO RETRIEVE THE SPONGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOOTHETTE ORAL SWAB KXF SAGE PRODUCTS INC. 5602 *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR