BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVAGE NASAL IRRIGATION KIT

    MDR report key: 24489908 · Received March 2, 2026

    Report

    Report Number
    MW5184601
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    October 22, 2024
    Report Date
    February 26, 2026
    Manufacturer
    RHINOSYSTEMS INC.
    Product Code
    KMA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A NAVAGE DEVICE (THE POWERED ONE) IN (B)(6) 2024. JUST WANTED SOMETHING TO CLEAN OUT MY SINUSES WITH. HAD BEEN USING NETI POTS. I ONLY USED THIS DEVICE ONCE. THE POWERED DEVICE SENT AN EXTREMELY POWERFUL BLAST OF WATER THROUGHOUT MY SINUSES AND INTO MY EUSTACHIAN TUBE AND CLOGGED MY RIGHT EAR WITH WATER. IT IS NOW LATE (B)(6) 2026 AND I STILL HAVE WATER IN MY RIGHT EAR CONFIRMED BY CT SCAN. I HAVE SEEN 5 ENT DOCTOR'S ABOUT THIS AND AM NOW GOING TO SEE AN OTOLOGIST TO SEE WHAT CAN DONE. AFTER WELL OVER A YEAR OF THIS I ALLOWED ONE OF THE ENT'S TO PUT A TUBE IN MY RIGHT EAR TO SEE IF THE FLUID WOULD DRAIN BUT IT DID NOT WORK. THIS FLUID WHICH IS BEHIND THE MASTOID IN MY RIGHT EAR IS CAUSING HEARING PROBLEMS, CONFIRMED ON AUDIOLOGY REPORTS, AND BALANCE PROBLEMS, FULL FEELING ON MY HEAD, VESTIBULAR TYPE SYMPTOMS. ANYTIME I GET A COLD OR URI NOW IT MAKES IT MUCH WORSE. PRIOR TO THIS I HAVE NEVER IN MY LIFE HAD ANY EAR PROBLEMS OF ANY KIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553637 NAVAGE NASAL IRRIGATION KIT IRRIGATOR, POWERED NASAL KMA RHINOSYSTEMS INC. SDG-2

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other ALLOPURINOL.| BENAZEPRIL/HTCZ.| METAMUCIL.| MVA.| OMEPRAZOLE.| OSTEO BIOFLEX.| PEPCID.| QUNOL TURMERIC.| SYNTHROID.| WELLBUTRIN.| XYZAL.| ZOCOR.