BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVAGE NASAL IRRIGATOR

    MDR report key: 18240132 · Received November 29, 2023

    Report

    Report Number
    MW5148607
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    November 22, 2023
    Report Date
    November 28, 2023
    Manufacturer
    RHINOSYSTEMS, INC.
    Product Code
    KMA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A NAVAGE AND THE DEVICE WORKS AS STATED, BUT I HAVE FOUND THAT WHEN USING DO NOT SWALLOW OR CLEAR YOUR EARS BECAUSE WATER WILL BE FORCED INTO YOUR MIDDLE EAR AND YOU MAY NEVER GET IT OUT BECAUSE WHEN YOU CLEAR YOUR EARS YOUR PUSHING AIR UP YOUR DRAINAGE CANALS WATER IS STOPPED FROM DRAINING BECAUSE OF THE AIR PRESSURE! AND WHEN I SWALLOWED IT OPENED UP AND I FELT WATER ENTER IN I IMMEDIATELY STOPPED IT ONLY AFFECTED MY RIGHT EAR THANK GOD, AND NOW I HAVE EXTREME ANXIETY AND I'M FROZEN IN FEAR! THE NAVAGE DEVICE WORKS AS STATED, BUT A WARNING NOT TO SWALLOW WHILE IN USE SHOULD BE STATED IN THE DIRECTIONS FOR USE!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430425 NAVAGE NASAL IRRIGATOR IRRIGATOR, POWERED NASAL KMA RHINOSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Disability