BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE

    MDR report key: 10128211 · Received June 5, 2020

    Report

    Report Number
    MW5094865
    Event Type
    Injury
    Date Received
    June 5, 2020
    Date of Event
    November 5, 2020
    Report Date
    May 26, 2020
    Manufacturer
    GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC /GSK CONSUMER HEALTHCARE
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD DRY MOUTH WHILE RECOVERING FROM SURGERY. USED ¿BIOTENE¿ DRY MOUTH ORAL RINSE. VERY BAD LINGERING TASTE. SPIT IT OUT. IT SMELLED LIKE SOMETHING I SMELLED IN (PROFANITY) HOUSE CLEANING. DECIDED TO TRY TO CLEAN RIND OUT OF TOILET BOWL. DID SPLENDID JOB. TOILET VERY CLEAN. I BELIEVE SOMEBODY REPLACED CONTENTS OF BIOTENE BOTTLE WITH TOILET BOWL CLEANER AND IS SELLING ON THE MARKET AS DRY MOUTH ORAL RINSE; MADE IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588581 BIOTENE SALIVA, ARTIFICIAL LFD GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC /GSK CONSUMER HEALTHCARE 9L224C

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR