BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASONEB

    MDR report key: 17710429 · Received September 7, 2023

    Report

    Report Number
    MW5145357
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    September 1, 2023
    Report Date
    September 3, 2023
    Manufacturer
    MONAGHAN MEDICAL CORPORATION
    Product Code
    JPW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I'VE PURCHASED THREE NASONEB SYSTEMS FOR TREATMENT OF FUNGAL SINUSITIS AND EACH ONE HAS BROKEN WITHIN ONE WEEK. REFERENCE REPORTS: MW5145356, MW5145358.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150107 NASONEB PUMP, NEBULIZER, ELECTRICALLY POWERED JPW MONAGHAN MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Required Intervention AMPHOTERICIN, ALL THROUGH NASONEB| BUDESONIDE| GENTAMICIN | VITAMIN B12X| VITAMIN C