BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL CARE KIT SUCTION SWAB

    MDR report key: 7536868 · Received May 22, 2018

    Report

    Report Number
    MW5077404
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 15, 2018
    Report Date
    May 18, 2018
    Manufacturer
    MEDLINE
    Product Code
    NXZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RRT WAS PERFORMING ORAL CARE AND THE ORAL CARE SWAB CAME OFF IN PATIENT'S MOUTH. NO HARM TO PATIENT NOTED. THE RRT STATES, IT APPEARED THE GLUE DID NOT STICK. REMOVED GREEN SPONGE BY SWIPING IT OUT OF MOUTH. STRENGTH: CHG 0.12 PERCENT ORAL RINSE UNK - UNKNOWN. DOSE OR AMOUNT: 1 UNK - UNKNOWN. FREQUENCY: 4 TIMES A DAY. ROUTE: ORAL. THERAPY START DATE: (B)(6) 2018. THERAPY END DATE: (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: TO PREVENT PNEUMONIA IN A VENTILATED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378198 ORAL CARE KIT SUCTION SWAB ORAL CARE KIT SUCTION SWAB NXZ MEDLINE 18-036-1

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR