BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVAGE

    MDR report key: 16132154 · Received January 9, 2023

    Report

    Report Number
    MW5114241
    Event Type
    Injury
    Date Received
    January 9, 2023
    Date of Event
    December 29, 2022
    Report Date
    January 5, 2023
    Manufacturer
    RHINOSYSTEMS, INC.
    Product Code
    KMA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WENT TO USE NAVAGE NASAL MACHINE. MACHINE FAILED TO PRIME AND AIR WAS SENT INTO SINUS PASSAGES CAUSING EXTREME PAIN SWELLING AND DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680914 NAVAGE IRRIGATOR, POWERED NASAL KMA RHINOSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Disability| R