BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE

    MDR report key: 5725460 · Received June 13, 2016

    Report

    Report Number
    MW5062841
    Event Type
    Injury
    Date Received
    June 13, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 11, 2016
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    NTO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED BIOTENE DRY MOUTH ORAL RINSE FOR 4 DAYS, I NOTICED ON THE 3RD DAY MY TEETH SEEMED SENSITIVE TO DRINKS. BY THE 4TH DAY, IT HURTS TO EVEN TOUCH MY TEETH. BY THE END OF THAT DAY, PART OF MY FILLING HAD FELL OUT. IT TOOK ALMOST A WEEK FOR MY TEETH TO FEEL NORMAL AGAIN. DOSE OR AMOUNT: TABLESPOON. FREQUENCY: TWICE A DAY. ROUTE: TAKEN BY MOUTH. DATES OF USE: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374577 BIOTENE DRY MOUTH ORAL RINSE BIOTENE DRY MOUTH ORAL RINSE NTO GLAXOSMITHKLINE 6D14C2A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR