BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVAGE NOSE CLEANER

    MDR report key: 21664868 · Received March 21, 2025

    Report

    Report Number
    MW5167950
    Event Type
    Injury
    Date Received
    March 21, 2025
    Date of Event
    March 12, 2025
    Report Date
    March 14, 2025
    Manufacturer
    RHINOSYSTEMS, INC.
    Product Code
    KDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED THE NAVAGE NOSE CLEANER ONE TIME. THE SUCTION WAS VERY POWERFUL. WITHIN AN HOUR, I DEVELOPED BRUISING AND REDNESS AROUND MY EYES. MY LEFT EYE WAS SIGNIFICANTLY WORSE THAN MY RIGHT EYE. TWO DAYS LATER, THE BRUISING AND REDNESS IS STILL THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696103 NAVAGE NOSE CLEANER BOTTLE, COLLECTION, VACUUM KDQ RHINOSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other