BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGE ORAL CARE KIT

    MDR report key: 4002581 · Received August 11, 2014

    Report

    Report Number
    MW5037697
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    June 5, 2011
    Report Date
    June 6, 2011
    Manufacturer
    SAGE PRODUCTS, INC.
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SAGE ORAL CARE KIT SUCTION SPONGE COMPONENT WAND BREAKING AT THE BASE OF THE SPONGE CAUSING THE SPONGE TO REMAIN IN PATIENT'S MOUTH AND BREAKING AT THE BASE OF THE THUMBPORT. DIAGNOSIS OR REASON FOR USE: ORAL CARE FOR INTUBATED PATIENT (PNEUMONIA PREVENTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474951 SAGE ORAL CARE KIT TOOTHETTE ORAL CARE SUCTION SWAB WITH PERO-A-MINT KXF SAGE PRODUCTS, INC. #6804 25354/1

    Patients

    Seq Age Sex Outcome Treatment
    1