BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVAGE NASAL CARE

    MDR report key: 19713952 · Received July 9, 2024

    Report

    Report Number
    MW5157153
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    November 29, 2023
    Report Date
    July 5, 2024
    Manufacturer
    RHINOSYSTEMS, INC.
    Product Code
    KMA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    11/4/2023 RECEIVED MY NEW NAVAGE NOSE IRRIGATION MACHINE USED NAVAGE NOSE IRRIGATION MACHINE FOR 3 TIMES OVER THE NEXT WEEK, USING PROPER INSTRUCTIONS; (B)(6) 2023 ¿ MY RIGHT EAR HAD SWELLED UP LIKE 3 TIMES THE SIZE AND DOWN THE SIDE OF MY NECK WAS IN PAIN. MY EAR WAS RINGING. THE DOCTOR ASKED IF I HAD BEEN ON VACATION OR SWIMMING SOMEWHERE, BUT I SAID NO AND SAID I HAD DEVELOPED SWIMMER'S EAR WITH WATER TRAPPED BEHIND MY EAR DRUM. DR. PRESCRIBED AMOXICILLIN FOR 10 DAYS, NEOMYCIN-POLYMYXIN EAR DROPS FOR 4 DAYS AND MUPIROCIN OINTMENT FOR 7 DAYS. ON (B)(6) 2023 ¿ EAR STILL NOT BETTER. DR. PRESCRIBED AZITHROMYCIN (ZPAC) FOR SEVERAL DAYS (B)(6) 2024 FOLLOW UP WITH DR. STILL NOT BETTER AND RINGING IN MY EAR. DID BLOOD WORK AND REFERRED ME TO AN ENT DR. (B)(6) 2024, ENT DR. DID HEARING TEST AND PARTIAL LOSS OF HEARING IN MY RIGHT EAR AND STILL RINGING IN MY EAR. PRESCRIBED PREDNISONE 10MG (42 PILLS) TO BE TAKEN OVER THE NEXT 10 DAYS. ON (B)(6) 2024 FOLLOW UP WITH ENT DR. NOW ORDERED MRI. ON (B)(6) 2024 COMPLETED MRI (B)(6) 2024 ¿ FOLLOW UP WITH ENT DR. AND SAID PERMANENT DAMAGE TO THE (B)(6) 2024 ¿ IN DISBELIEF I THOUGHT WELL MAYBE IT WILL HEAL IN TIME. I STILL HAVE CONSTANT RINGING IN MY EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348211 NAVAGE NASAL CARE IRRIGATOR, POWERED NASAL KMA RHINOSYSTEMS, INC. SDG-2

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Disability| R MULTIVITAMIN