BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVAGE NASAL IRRIGATION SYSTEM

    MDR report key: 18302858 · Received December 8, 2023

    Report

    Report Number
    MW5149082
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    November 15, 2023
    Report Date
    December 6, 2023
    Manufacturer
    RHINOSYSTEMS, INC.
    Product Code
    KMA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ORDERED THE NAVAGE NASAL CARE STARTER BUNDLE NOSE CLEANER FROM WALMART ON (B)(6) HAD IT DELIVERED TO (B)(6), WHERE I WORK; ALONG WITH 1 GALLON OF PURE LIFE DISTILLED WATER. USED IT TWICE THAT DAY AND EVERYTHING WAS OKAY. IT OPENED UP MY NASAL PASSAGES AND CLEARED THE CONGESTION. ON (B)(6) I USED IT AGAIN. THIS TIME IT FELT WEIRD. MY EARS POPPED AND FELT TIGHT WHICH MADE ME PUT THE MACHINE INTO THE CABINET AND I HAVE NOT USED IT SINCE. HOWEVER, EVER SINCE THIS TIME, I'VE FELT PRESSURE IN MY EARS AND JUST FELT WEIRD. I'VE SINCE BEEN TO ACCESS URGENT CARE 3 TIMES, BEEN DIAGNOSED WITH A DOUBLE EAR INFECTION AND PRESCRIBED TWO SETS OF 10 DAY ANTIBIOTICS. YESTERDAY, (B)(6) 2023 I WENT TO AN APPOINTMENT WITH AN ENT(EAR, NOSE, THROAT DOCTOR) AND WAS TOLD I HAVE NEGATIVE EAR PRESSURE MY EAR DRUMS ARE SUCKED INWARD. I FULLY BELIEVE THE SUCTION FROM THE NAVAGE CAUSED THIS AND I MAY NOW NEED TUBES IN MY EARS TO RELEASE THE SUCTION AND ALLOW MY EAR DRUMS TO RETURN BACK TO A NORMAL STATE OF PRESSURE! NAVAGE DOES NOT DISCLOSE, NOR SHOW, WATER EVEN ENTERING INTO YOUR EARS. IT SIMPLY SHOWS IT GOING THROUGH ONE NOSTRIL AND OUT THE OTHER! THIS HAS BEEN A COSTLY, UNCOMFORTABLE AND AWFUL EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252109 NAVAGE NASAL IRRIGATION SYSTEM IRRIGATOR, POWERED NASAL KMA RHINOSYSTEMS, INC. VIPRB-00422

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Other| R| S "TWO SETS OF 10 DAY ANTIBIOTICS".| LEVOTHYROXINE 200 MCG.| PURE LIFE DISTILLED WATER.