BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE PRODUCTS

    MDR report key: 19528759 · Received June 12, 2024

    Report

    Report Number
    MW5156210
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    May 7, 2024
    Report Date
    June 7, 2024
    Manufacturer
    HALEON US HOLDINGS LLC
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE BEEN USING BIOTENE TOOTHPASTE, SPRAY & MOUTH RINSE FOR DRY MOUTH. THE LONGER I HAD USED IT, THE MORE MY MOUTH BECAME SORE. MY DENTIST TREATED THE ISSUE AS CANDIDA WITH CLOTRIMAZOLE 10 MG. THIS HAD HELP TO REDUCE THE SORES AND QUICKLY RETURNED. I HAVE STOPPED USING THE BIOTENE PRODUCTS AND ALREADY BEGINNING TO NOTICE A CHANGE. HOPING THIS CORRECTS THE ISSUE. PERHAPS OTHERS HAVE HAD THE PAINFUL RED AND SPLOTCHES OF WHITE WHILE USING THE PRODUCT. QUIT USING THE BIOTENE. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2024. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189119 BIOTENE PRODUCTS SALIVA, ARTIFICIAL LFD HALEON US HOLDINGS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female BIOTIN 10000 MCG.| CITROCAL + D3 TWO TABS DAILY. | IC CITALOPRAM HBR 20 MG.| LEVOTHYROXINE 88MCG. | NIFEDIPINE ER 30 MG. | VIT. E 450 MG TWICE DAILY.