BEUDAMED
    FDA Adverse Event Summary report: N

    SINUFLO

    MDR report key: 16496196 · Received March 7, 2023

    Report

    Report Number
    MW5115475
    Date Received
    March 7, 2023
    Report Date
    March 5, 2023
    Manufacturer
    NEILMED PHARMACEUTICALS, INC.
    Product Code
    KCJ
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NEILMED SINUFLO- I WAS UNABLE TO GET THE SEAL OFF COMPLETELY BECAUSE IT IS VERY HARD TO GET OFF. SO PART OF THE FOIL SEAL WAS LEFT ON THE RIM OF THE BOTTLE. THE INSTRUCTIONS SAY TO WARM IT FOR 5-10 SECONDS IN THE MICROWAVE- WHEN I DID SO (JUST FOR FIVE SECONDS) THE SEAL ON THE RIM CAUGHT FIRE AND BURNED PART OF THE BOTTLE. THERE WAS A MINI-EXPLOSION IN MY MICROWAVE AND A BRIGHT BURNING LIGHT. THE SEAL SHOULD REMOVE MORE EASILY OR THEY SHOULD INCLUDE A WARNING ABOUT THIS. I THREW IT AWAY BUT I IMAGINE USING IT WITH BURNED PLASTIC COULD BE DANGEROUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86223 SINUFLO APPLICATOR, ENT KCJ NEILMED PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female