BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEILMED SINUS RINSE BOTTLE

    MDR report key: 19373445 · Received May 21, 2024

    Report

    Report Number
    MW5155211
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    May 17, 2024
    Report Date
    May 18, 2024
    Manufacturer
    NEILMED PHARMACEUTICALS, INC.
    Product Code
    KCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE USED NEILMED SINUS RINSE BOTTLES FOR YEARS. I REPLACE THEM EVERY 60 DAYS. OVER THE PAST 3-4 YEARS, THE QUALITY OF THE BOTTLES HAS GONE DOWNHILL. THE BLACK LETTERING ON THEIR BOTTLES WILL FLAKE OFF. IT IS NOT ALL BOTTLES, I WOULD SAY ABOUT 1 OUT OF EVERY 5-6 BOTTLE I USE. THE BLACK MATERIAL GETS ALL OVER AND INTO THE RINSE WATER WHICH IS DANGEROUS BECAUSE IT COULD END UP GOING INTO YOUR SINUSES AND YOUR BODY. I HAVE SENT NUMEROUS COMPLAINTS OVER THE YEARS TO THE NEILMED ABOUT THEIR QUALITY ISSUES. TODAY I OPENED A BOTTLED BRAND NEW, UNUSED AND ... THE BLACK LETTERING CAME OFF AND GOT ALL OVER EVERYTHING. THIS COMPANY HAS DONE NOTHING TO ADDRESS SUCH A SIMPLE PROBLEM. EACH TIME THEY JUST SEND ME A NEW BOTTLE. THEY NEED TO FIX THIS ISSUE SO THE BLACK MATERIAL THAT'S COMING OFF ON SOME OF THEIR BOTTLES DOESN'T INJURE SOMEONE. SEVERAL LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305037 NEILMED SINUS RINSE BOTTLE APPLICATOR, ENT KCJ NEILMED PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention