BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOOTHETTE ORAL CARE SUCTION SWAB

    MDR report key: 1929306 · Received December 2, 2010

    Report

    Report Number
    1929306
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 2, 2010
    Manufacturer
    SAGE PRODUCTS, INC.
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE ORAL CARE DEVICE (PLASTIC AND SPONGE) BROKE OFF IN PATIENT'S MOUTH WHILE NURSE WAS BRUSHING TEETH. IT WAS DIFFICULT TO REMOVE FROM PATIENT'S MOUTH. THE TIP WAS REMOVED WITH NO ADVERSE OUTCOME.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOOTHETTE ORAL CARE SUCTION SWAB TOOTHETTE ORAL CARE SUCTION SWAB JOL SAGE PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR