BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVAGE

    MDR report key: 16707323 · Received April 7, 2023

    Report

    Report Number
    MW5116489
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    April 5, 2023
    Report Date
    April 5, 2023
    Manufacturer
    RHINOSYSTEMS, INC.
    Product Code
    KMA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    EXTREME EAR PAIN AFTER PRODUCT USAGE. RINGING IN EAR PERSISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019575 NAVAGE IRRIGATOR, POWERED NASAL KMA RHINOSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Disability| O ALGAE OIL | ECHINACEA | FINASTERIDE| MULTIVITAMIN VIT B12 | ZINC