BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEILMED NASOGEL DRY NOSES DRIP FREE SPRAY

    MDR report key: 21141818 · Received January 10, 2025

    Report

    Report Number
    MW5164588
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    December 19, 2024
    Report Date
    January 9, 2025
    Manufacturer
    NEILMED PHARMACEUTICALS, INC.
    Product Code
    KCO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BEGAN USING NEILMED NASOGEL DRY NOSES DRIP FREE SPRAY ON (B)(6) 2024. THE NOSE SPRAY CAUSED SEVERE CONGESTION, SEVERE THROAT BURNING, SEVERE BURNING IN NOSE, BURNING IN BOTH EYES, NAUSEA, SINUS PRESSURE, NOSE BLEEDS, AND A HEADACHE. THE SYMPTOMS WORSENED AS I CONTINUED TO USE THE PRODUCT AND DID NOT BEGIN TO EASE UNTIL I DISCONTINUED USING THE PRODUCT AFTER REALIZING IT MAY HAVE BEEN CAUSING THE PROBLEM. I HAVE SINCE DISCOVERED THAT THE SPRAY I WAS USING WAS PART OF A RECALL DUE TO MICROBIAL CONTAMINATION. I AM STILL HAVING THROAT BURNING AND CONGESTION. DATES OF USE: (B)(6) 2024 - (B)(6) 2025. REASON FOR USE: DRY NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897896 NEILMED NASOGEL DRY NOSES DRIP FREE SPRAY NASAL SPRAY, ENT DELIVERY KCO NEILMED PHARMACEUTICALS, INC. NGS762

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Disability