BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVAGE NASAL CARE

    MDR report key: 14021607 · Received April 5, 2022

    Report

    Report Number
    MW5108787
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    December 2, 2020
    Report Date
    April 2, 2022
    Manufacturer
    RHINOSYSTEMS, INC.
    Product Code
    KMA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED NAVAGE NOSE IRRIGATION MACHINE ONE YEAR AND FOUR MONTHS AGO, TWICE, EACH TIME LESS THAN A MINUTE ON (B)(6) 2020. WHEN I USED IT I FELT PAIN IN MY MIDDLE EARS. BECAUSE OF THIS I STOPPED USING IT AND RETURNED IT TO THE VENDOR. BUT THE PAIN DIDN'T GO AWAY. AFTER ONE YEAR AND FOUR MONTHS STILL I HAVE CONSTANT PAIN, PRESSURE, AND CONGESTION IN BOTH OF MY MIDDLE EARS. IT IS VERY ANNOYING. IN ADDITION, AFTER I USED NAVAGE I GOT INFECTION IN BOTH OF MY MIDDLE EARS AND I TOOK ANTIBIOTICS FOR ONE MONTH. I HAVE VISITED SEVERAL ENT SPECIALISTS. SO FAR THEY HAVEN'T BEEN ABLE TO HELP. I HAVE ALSO HAD SEVERAL TESTS INCLUDING CT SCAN OF MY MIDDLE EARS, AUDIOGRAM, AND TYMPANOMETRY. IN TOTAL, I VISITED SEVEN DOCTORS: FOUR ENT SPECIALISTS AND THREE URGENT CARE PHYSICIANS. IF I KNEW WATER GOES INTO MY MIDDLE EARS, I WOULD NOT HAVE BOUGHT NAVAGE. NAVAGE PRESENTATION DOESN'T SHOW THAT WATER GOES INTO OUR MIDDLE EARS. PLEASE SEE THEIR WEBSITE AT WWW.NAVAGE.COM. IT SHOWS THAT WATER GOES INTO ONE NOSTRIL AND COMES BACK FROM THE OTHER NOSTRIL. BUT IN REALITY WATER FIRST GOES FROM OUR EUSTACHIAN TUBE INTO OUR MIDDLE EARS. THEN THE OVERFLOW WATER COMES BACK FROM THE OTHER NOSTRIL. AT THE TIME THAT I BOUGHT NAVAGE I DIDN'T KNOW THAT THERE IS A TUBE THAT CONNECTS OUR NOSTRIL TO OUR MIDDLE EAR. ALSO, NAVAGE GIVES US THE OPTION TO USE EITHER FILTERED WATER OR DISTILLED WATER FOR THE IRRIGATION. IF THEY ASKED US TO USE ONLY DISTILLED WATER, I MAY NOT HAVE GOTTEN MIDDLE EAR INFECTION. IT IS INSANE THAT I USED NAVAGE JUST FOR A FEW SECONDS AND IT HAS CAUSED ME CONSTANT PAIN, PRESSURE, CONGESTION, AND DISCOMFORT IN BOTH OF MY MIDDLE EARS FOR ONE YEAR AND FOR MONTHS. I AM WORRIED THAT THIS PROBLEM WILL STAY WITH ME FOR THE REST OF MY LIFE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938992 NAVAGE NASAL CARE IRRIGATOR, POWERED NASAL KMA RHINOSYSTEMS, INC.
    938993 NAVAGE NASAL CARE IRRIGATOR, POWERED NASAL KMA RHINOSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| S