BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASONEB NASAL NEBULIZER

    MDR report key: 5957806 · Received September 16, 2016

    Report

    Report Number
    1648287-2016-00001
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    July 18, 2016
    Report Date
    August 24, 2016
    Manufacturer
    MEDINVENT, LLC
    Product Code
    JPW
    UDI-DI
    8911700000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THIS IS A PRE-EXISTING CONDITION. WE DO NOT BELIEVE THE NASONEB AND N-ACETYLCYSTEINE CONTRIBUTED TO THE LOSS OF SENSE OF SMELL AS IT CONTINUED TO GET WORSE AFTER SHE DISCONTINUED USE OF THE NASONEB AND MEDICATION. THE HISTORY IS INCONSISTENT WITH THE REPORT OF A FEW WEEKS OF USE AS THE PATIENT REFILLED THE PRESCRIPTION AFTER 30 DAYS. IT DOES NOT APPEAR THAT THE OTHER MEDICATIONS WOULD CONTRIBUTE TO HYPOSMIA. MILD BLEEDING UPON USE IS NORMAL AT FIRST USE WHEN THERE IS CRUSTING OR INFECTION CAUSING THE NOSE TO BLEED. N-ACETYLCYSTEINE HAS BEEN ASSOCIATED WITH PAIN ON DELIVERY AND MUCOSAL BLEEDING, THE LABELING FOR THE COMMERCIAL PRODUCT STOPS SHORT OF CALLING OUT A CAUSATIVE RELATIONSHIP. THE PATIENT CHANGED DOCTORS AND THE NEW ENT, (B)(6), PRESCRIBED INTRANASAL CORTICOSTEROIDS. HE SUSPECTS THAT THE REDUCTION IN SENSE OF SMELL IS FROM INFLAMMATION, THIS IS POSSIBLY DUE TO THE WITHDRAWAL OF THE MUCINEX D FROM HER REGIMEN. THE N-ACETYLCYSTEINE WAS COMPOUNDED AT (B)(6), LOT NUMBERS 05172016@2, 06162016@59, 02122016@33. THE BUD IS 11/3/2016. THE DOSING IS 200 MG. BID/TID. THE LEADER BRAND SALINE LOT NUMBER IS UNKNOWN. THE BUD DATE ON THE SALINE IS 1 YEAR FROM DISPENSING ACCORDING TO THE PHARMACIST. OTHER MEDICATIONS INCLUDED: LEXAPRO, VALTREX, MILAXACAM, VAGISIM. DOSAGE ARE UNKNOWN. THE DELAY IN REPORTING WAS DUE TO THE LENGTH OF TIME IT TOOK TO OBTAIN A WEBTRADER ACCOUNT. DEVICE FUNCTIONED PROPERLY.

    Description of Event or Problem · 1

    (B)(6) REPORTS THAT A PATIENT COMPLAINS OF A REDUCED SENSE OF SMELL AFTER A FEW WEEKS OF USE WITH N-ACETYL CYSTEINE. PATIENT HAD DISCONTINUED USE FOR 3 WEEKS. SHE STATED THAT SHE HAD NOTICED A REDUCTION IN SMELL AFTER THE FIRST FEW DOSES AND IT BECAME MORE NOTICEABLE OVER TIME. PATIENT WAS PRESCRIBED N-ACETYLCYSTEINE FOR CHRONIC CONGESTION AFTER LONG TERM USE OF MUCINEX-D (GUAIFENESIN AND PSEUDOEPHEDRINE) WHICH WAS CONCOMITANTLY DISCONTINUED WITH THE INITIATION OF N-ACETYLCYSTEINE. N-ACETYLCYSTEINE WAS COMPOUNDED IN A DRY POWDER FORMULATION (LOXASPERSE, PCCA) AND PROVIDED LEADER BRAND SALINE WOUND WASH BY (B)(6) PHARMACY. ACCORDING TO THE LABEL, THERE ARE NO PRESERVATIVES IN THE SALINE WASH. PATIENT COMPLAINED OF PAIN FOR 30-60 MINUTES AFTER USING THE DEVICE AND IRRITATION OF THE NASAL PASSAGES. PATIENT NOTED BLOOD IN THE CUP AND WHEN BLOWING HER NOSE AFTER THERAPY WHICH WAS SELF-LIMITING. PATIENT INDICATED NO HISTORY OR VIRAL INFECTION. IT IS UNCLEAR WHY THEN SHE IS ON VALTREX. NO REPORTED HISTORY OF SURGERY. SHE SWITCHED DOCTORS AND THE NEW ENT, (B)(6), PRESCRIBED INTRANASAL CORTICOSTEROIDS. HE SUSPECTS THAT THE REDUCTION IN SENSE OF SMELL IS FROM INFLAMMATION, THIS IS POSSIBLY DUE TO THE WITHDRAWAL OF THE MUCINEX D FROM HER REGIMEN. QUESTIONS FOR THE MD: ENDOSCOPIC PRESENTATION - WAS THERE ANYTHING REMARKABLE WITH RESPECT TO THE HYPOSMIA? CRUSTING, OPEN SORES? WHAT LOCATION? DID HE FIND ANY EVIDENCE OF WHY SHE WAS HAVING BLEEDING? DID THE OLFACTORY CLEFT APPEAR REMARKABLE? NO REMARKABLE FINDINGS WITH ENDOSCOPIC EXAM. NO OPEN SORES, CRUSTING, EVIDENCE OF BLEEDING OR ANY SIGN OF INJURY TO NASAL PASSAGES. CULTURE NEGATIVE FOR INFECTION. DOES HE BELIEVE THE N-ACETYLCYSTEINE CONTRIBUTED TO THE HYPOSMIA? WHY OR WHY NOT? DOES HE BELIEVE THE NASONEB CONTRIBUTED TO THE HYPOSMIA? WHY OR WHY NOT? HE IS UNSURE AS TO WHAT COULD BE THE CAUSATIVE FACTOR. IT IS AN UNEXPECTED REACTION WITH THERAPIES BEING USED. DOES HE BELIEVE THE DISCONTINUATION OF MUCINEX-D CONTRIBUTED TO THE HYPOSMIA? WHY OR WHY NOT?DOES HE BELIEVE THE N-ACETYLCYSTEINE WAS AN APPROPRIATE PRESCRIPTION FOR HER CONDITION? WHY OR WHY NOT? IN HIS OPINION, WHAT DID HE THINK WAS THE UNDERLYING CAUSE FOR THE HYPOSMIA AND THE TIMING OF ITS ONSET? UNCLEAR. HE DID NOT BELIEVE THE NASONEB AND N-ACETYLCYSTEINE CONTRIBUTED. WHAT CORTICOSTEROID IS HE PRESCRIBING AND WHAT IS THE ROUTE OF ADMINISTRATION AND THE ADMINISTRATION DEVICE? FLONASE. THIS IS AN CONTINUATION OF A PRESCRIPTION. IT IS NOT CLEAR WHY THE PATIENT INITIALLY STOPPED TAKING THIS. PATIENT HAS NOT FOLLOWED UP WITH PHARMACY SINCE INITIAL CONVERSATION IN (B)(6). CURRENTLY UNAWARE IF THE CONDITION HAS SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609856 NASONEB NASAL NEBULIZER NASAL NEBULIZER JPW MEDINVENT, LLC 5070 N/A 8911700000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Disability LEADER BRAND SALINE WASH| N-ACETYLCYSTEINE - COMPOUNDED