BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVAGE NASAL CARE SALINE NASAL IRRIGATION

    MDR report key: 14117505 · Received April 14, 2022

    Report

    Report Number
    MW5108998
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    April 8, 2022
    Report Date
    April 12, 2022
    Manufacturer
    RHINOSYSTEMS, INC.
    Product Code
    KMA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USED NAVAGE FOR FIRST TIME IN CORRECT MANNER AFTER THOROUGHLY READING INSTRUCTIONS TO IRRIGATE NASAL PASSAGE. SALINE ENTERED SINUSES CAUSING SEVERE PRESSURE IN BOTH EARS. PAIN CONTINUED TO INTENSIFY FOR MANY DAYS WITH INCREASED PRESSURE; 3 DAYS POST INJURY A ENT SPECIALIST WAS SEEN. ENT FOUND A HEMATOMA ON THE LEFT EARDRUM CAUSED BY SEVERE INNER EAR PRESSURE. TYMPANOMETRY REVEALED A FLAT LINE IN THE LEFT EAR DUE TO THE SEVERE PRESSURE IN THE INNER EAR. AUDIOLOGY REVEALED LOSS OF HEARING AT HIGH FREQUENCIES. ENT SPECIALIST PRESCRIBED PREDNISONE STEROID AND AMOX-CLAV ANTIBIOTIC. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168038 NAVAGE NASAL CARE SALINE NASAL IRRIGATION IRRIGATOR, POWERED NASAL KMA RHINOSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention