BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEILMED NASOGEL DRIP FREE GEL SPRAY, 1 FLUID OUNCE, SINUS RELIEF

    MDR report key: 21125244 · Received January 9, 2025

    Report

    Report Number
    MW5164535
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    January 7, 2025
    Report Date
    January 7, 2025
    Manufacturer
    NEILMED PHARMACEUTICALS, INC.
    Product Code
    KCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED AN EMAIL FROM AMAZON THAT A PRODUCT I HAD ORDERED - NEILMED NASOGEL DRIP FREE GEL SPRAY, 1 FLUID OUNCE, SINUS RELIEF - HAD A POTENTIAL SAFETY ISSUE AND TO CONTACT (B)(4) AT [email protected]. THE EMAIL GAVE NO INFORMATION ABOUT THE POTENTIAL SAFETY ISSUE OR INSTRUCTIONS TO CEASE USE OR SEEK MEDICAL ATTENTION. I CONTACTED THE COMPANY DIRECTLY AT 8:49PM EST AT THE PHONE NUMBER LISTED ON THEIR WEBSITE (1-877-477-8633) AND THE REPRESENTATIVE I SPOKE WITH REFUSED TO GIVE ME ANY INFORMATION REGARDING THE POTENTIAL SAFETY ISSUE OTHER THAN "IT IS A VARIANCE, SO WE ARE RECALLING IT FOR SAFETY". WHEN I ASKED WHAT KIND OF VARIANCE, SHE REFUSED TO GIVE ME ANY INFORMATION. I SAID IT WAS UNACCEPTABLE AS I HAD BEEN USING THE PRODUCT AND WANTED TO KNOW IF I SHOULD SEEK MEDICAL ATTENTION. SHE REFUSED TO GIVE ME ANY INFORMATION OR ALLOW ME TO SPEAK WITH ANOTHER REPRESENTATIVE. I USED TO PRODUCT ONLY TEN MINUTES BEFORE RECEIVING THE EMAIL OF THE SAFETY NOTICE AND NOW I DON'T KNOW WHAT TO DO. I DON'T UNDERSTAND HOW A MEDICAL COMPANY CAN BE ALLOWED TO OPERATE WHEN THEY REFUSE TO INFORM THEIR CUSTOMERS OF POTENTIAL SAFETY ISSUES. A QUICK GOOGLE SEARCH SHOWS THEY ARE NOT AN UPSTANDING COMPANY WITH PRIOR CLEANLINESS/SAFETY VIOLATIONS NOTED BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656532 NEILMED NASOGEL DRIP FREE GEL SPRAY, 1 FLUID OUNCE, SINUS RELIEF APPLICATOR, ENT KCJ NEILMED PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown