BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASO-GEL TUBE

    MDR report key: 17886338 · Received October 5, 2023

    Report

    Report Number
    MW5146654
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    October 1, 2023
    Report Date
    October 5, 2023
    Manufacturer
    NEILMED PHARMACEUTICALS, INC.
    Product Code
    KCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED TO REPORT THAT AFTER USING NASOGEL, SHE EXPERIENCED SEVERE REACTIONS ON TWO SEPARATE OCCASIONS: ONE, (B)(6) 2023, SHE TOOK IT IN THE EVENING AND HAD CHILLS AND SHIVERING, NAUSEA AND VOMITING AND WAS ILL THROUGHOUT THE NIGHT AND HAD TO CANCEL HER PATIENT LOAD FOR THE FOLLOWING DAY. TWO, (B)(6) 2023, SHE TOOK NASOGEL AT NOON AND BY THE EVENING HAD CHILLS, DIZZINESS, NAUSEA AND VOMITING, DIARRHEA, LOSS OF CONSCIOUSNESS/FALLING AND HITTING HER HEAD WITH BLEEDING. HER HUSBAND WAS ABLE TO HELP HER ON THIS SECOND INCIDENT. REPORTER STATES THAT THE NASOGEL IS UNSANITARY, HAS MOLD AND TOXINS IN ITS INGREDIENTS, LACKS RIGOROUS TESTING BY THE MANUFACTURER AND QUALITY CONTROL PROBLEMS. REPORTER STATES THAT THE FDA HAS ISSUED WARNING LETTERS ABOUT THIS PRODUCT (MAY 26, 2023), HTTPS://WWW.FDA.GOV/INSPECTIONS-COMPLIANCE-ENFORCEMENT-AND-CRIMINAL-INVESTIGATIONS/WARNING-LETTERS/NEILMED-PHARMACEUTICALS-INC-650263-05262023 WHERE, THE PRODUCT CONTINUES TO BE A HAZARD TO THE PUBLIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942674 NASO-GEL TUBE APPLICATOR, ENT KCJ NEILMED PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other