BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEILMED SINUS RINSE

    MDR report key: 20291190 · Received September 20, 2024

    Report

    Report Number
    MW5159963
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    September 19, 2024
    Report Date
    September 19, 2024
    Manufacturer
    NEILMED PHARMACEUTICALS , INC.
    Product Code
    KCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS PRESCRIBED NEILMED SINUS RINSE AFTER MY NASAL SURGERY ON (B)(6) 2024. AFTER TWO DAYS OF USE, I NOTICED SMALL BLACK SPECKS ON THE INSIDE TUBE AND REALIZED THE PRINTING ON THE BOTTLE WAS DISINTEGRATING AND GETTING ALL OVER THE BOTTLE, INSIDE AND OUTSIDE. IT WAS ALSO OVER MY HANDS. I DID NOT REALIZE THIS UNTIL WHEN I WAS GENTLY BLOWING MY NOSE, AS REQUIRED, TO EXPEL THE LIQUID IN MY SINUSES, AND NOTICED IT WAS COMING OUT OF MY NOSE. I WAS GIVEN THE BOTTLE BY MY ENT (B)(6) SCHOOL, ON (B)(6) 2024. AFTER NASAL SURGERY - TURBINATES REDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244514 NEILMED SINUS RINSE APPLICATOR, ENT KCJ NEILMED PHARMACEUTICALS , INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male AZELASTINE HCL.| COQ10.| ESCITALOPRAM OXALATE.| IPRATROPIUM BROMIDE.| SENIOR MEN'S MULTIVITAMIN.| SIMVASTATIN.