BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-CARE ORAL CARE KIT

    MDR report key: 796640 · Received November 22, 2006

    Report

    Report Number
    796640
    Event Type
    Malfunction
    Date Received
    November 22, 2006
    Date of Event
    November 20, 2006
    Report Date
    November 22, 2006
    Manufacturer
    SAGE PRODUCTS, INC.
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO USE SUCTION CATHETER IN THE SAGE MOUTHCARE KIT FOR ORAL PATIENT CARE. NO SUCTION WAS OBSERVED. IT WAS NOTED THE SLIDE MECHANISM WAS NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Q-CARE ORAL CARE KIT CATHETER, SUCTION JOL SAGE PRODUCTS, INC. * 4052/1

    Patients

    Seq Age Sex Outcome Treatment
    1 *