BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVAGE NASAL CLEANER

    MDR report key: 20000341 · Received August 16, 2024

    Report

    Report Number
    MW5158583
    Event Type
    Injury
    Date Received
    August 16, 2024
    Date of Event
    March 6, 2003
    Report Date
    August 15, 2024
    Manufacturer
    RHINOSYSTEMS, INC.
    Product Code
    KMA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023, I USED THE NAVAGE NASAL IRRIGATION SYSTEM AND WITHIN 2 HOURS DEVELOPED RIGHT-SIDED BELL'S PALSY. I HAD USED THE SYSTEM PREVIOUSLY WITH NO ADVERSE EFFECTS, BUT ON THIS DAY, THE WATER WAS NOT AS WARM AS IT SHOULD HAVE BEEN. I BELIEVE THAT AS THE COOLER WATER IRRIGATED MY NASAL PASSAGES IT AFFECTED MY FACIAL NERVE WHICH CAUSED THE BELL'S PALSY. NOT KNOWING IF THIS WAS BELL'S PALSY OR A STROKE, I WENT TO THE EMERGENCY ROOM AND WAS WORKED UP FOR STROKE. THIS RESULTED IN A 23 HOUR STAY AND LARGE HOSPITAL BILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396890 NAVAGE NASAL CLEANER IRRIGATOR, POWERED NASAL KMA RHINOSYSTEMS, INC. 5DG-2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization ASPIRIN 81 MG| FLONASE| ROSUVASTATIN 5 MG| VITAMIN D 5000 UNITS| ZYRTEC 10 MG