BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEILMED SINUS RINSE

    MDR report key: 18572242 · Received January 23, 2024

    Report

    Report Number
    MW5150648
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    January 18, 2024
    Report Date
    January 20, 2024
    Manufacturer
    NEILMED PHARMACEUTICALS, INC.
    Product Code
    KCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AS AN AVID NEILMED NASAL SINUS RINSE USER (SINURINSE SQUEEZE BOTTLE) FOR THE PAST 5 YEARS I NOTICED A DIFFERENCE IN THE SMELL OF THE BOTTLE AND THE INNER TUBE ALMOST IMMEDIATELY UPON OPENING THE BOX AS I HAD DISPOSED OF THE PREVIOUS UNIT AS PER THE MANUFACTURER'S IFU. I CHECKED OTHER LOTS PURCHASED WITHIN THE PAST MONTH AND THEY ALL HAVE THE SAME VERY STRONG CHEMICAL SMELL EMITTING FROM THEM THAT DOES NOT GO AWAY AFTER THE CLEANING PROCESS OUTLINED IN THE MANUFACTURER'S IFU IS FOLLOWED. IMMEDIATELY AFTER USING THE AFFECTED UNIT WITH THE UNUSUALLY STRONG CHEMICAL ODOR ON IT I SUFFERED A STRONG BURNING SENSATION IN THE BACK OF MY HEAD AND DIZZINESS. I THEN COMPARED SOME OLDER EXTRA UNITS I HAD NOT YET OPENED TO DETERMINE IF THEY WERE AFFECTED AS WELL. OLDER LOTS THAT EXPIRE IN JULY 2026 (LOT #M060122) WERE NOT IMPACTED AND THE QUALITY WAS AS EXPECTED. HOWEVER, NEWER LOTS WITH AN EXPIRATION DATE OF AUGUST 2027 (LOT #M080123) DID EMIT THE STRONG CHEMICAL ODOR ON THE PARTS. THIS WAS TRUE OF SEVERAL UNITS FROM THE SAME, NEWER LOT NUMBER. IN PERFORMING SOME ONLINE RESEARCH IT SEEMS THE COMPANY CAME UNDER WARNING LETTER IN RECENT TIMES AND WAS CITED FOR SUB-PAR CLEANING OF THEIR MANUFACTURING EQUIPMENT. THERE MAY BE SOME CONNECTION BETWEEN THIS RECENT ISSUE AND THE CORRECTIONS/CORRECTIVE ACTIONS TAKEN BY THE COMPANY THAT UNKNOWINGLY IMPACTED DEVICE QUALITY IN A DIFFERENT MANNER. IT IS NOT CLEAR IF THE SMELL BEING EMITTED IS DUE TO (A) CHANGE IN MANUFACTURING MATERIALS, (B) MANUFACTURING PROCESSES, (C) PRODUCTION EQUIPMENT MAINTENANCE PRACTICES, OR (D) SOMETHING ELSE HOWEVER THIS ISSUE SEEMS TO BE ONE THAT SHOULD BE LOOKED INTO QUICKLY BY THE COMPANY AS THE INTRODUCTION OF UNKNOWN SUBSTANCES INTO THE NASAL PASSAGES THROUGH NASAL IRRIGATION CAN POSE RISKS TO THE PATIENT AND THESE RISKS SEEM NEW AND RELATED TO RECENT CHANGES THAT HAVE OCCURRED AT THE MANUFACTURER. PLEASE FOLLOW UP ON THIS ISSUE TO ENSURE FURTHER INVESTIGATION OCCURS AND THAT OTHER PATIENTS ARE NOT HURT IN THE SHORT TERM OR LONG TERM AS A RESULT OF THIS ISSUE. EID # (B)(6). APPEARS TO BE (B)(6) PER ACCESS DATABASE. HOWEVER, MODEL CONTAINS 50 VS 60 SALINE RINSE PACKETS AS IS INDICATED IN ACCESS DATABASE. OUTERBOX LABELING IS TIED TO P/N -EN-US-REV-PP20230726. REFERENCE REPORT: MW5150649.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2406284 NEILMED SINUS RINSE APPLICATOR, ENT KCJ NEILMED PHARMACEUTICALS, INC. 00705928001008 M080123

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other CLARITIN.| EMERGEN-C SUPPLEMENT.