BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEILMED NASOGEL

    MDR report key: 21161387 · Received January 14, 2025

    Report

    Report Number
    MW5164747
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    December 20, 2024
    Report Date
    January 10, 2025
    Manufacturer
    NEILMED PHARMACEUTICALS, INC.
    Product Code
    KCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ONE WEEK POST SINUS SURGERY MY EAR NOSE AND THROAT DOCTOR PRESCRIBED HOURLY USE OF NEILMED NASO GEL. I HAD PURCHASED 6 BOTTLES FOR USE AS RECOMMENDED BY THE ENT. WITHIN A FEW DAYS OF USE, I BEGAN THE SYMPTOMS OF A BAD SINUS INFECTION. I WAS RECENTLY SENT AN EMAIL THAT THE NEILMED NASOGEL WAS RECALLED DUE TO MICROBIAL CONTAMINATION. BECAUSE I HAD ALREADY DISPOSED OF THREE OF THE BOTTLES, I AM UNCERTAIN IF THEY FELL WITHIN THE LOTS RECALLED. AFTER STOPPING THE USE OF THE PRODUCT, THE SYMPTOMS HAVE SLOWLY DISSIPATED BUT THE RECOVERY TIME FROM THE SURGERY WAS FOUR TIMES LONGER THAN IT SHOULD HAVE BEEN. REASON FOR USE: RECOMMENDED FOLLOWING SINUS REPAIR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275010 NEILMED NASOGEL APPLICATOR, ENT KCJ NEILMED PHARMACEUTICALS, INC. NGS775

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female FISH OIL| MULTI-VITAMIN| PROBIOTICS| TAMOXIFEN| VEOZAH