BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE

    MDR report key: 2925258 · Received January 17, 2013

    Report

    Report Number
    2022474-2013-00002
    Event Type
    Other
    Date Received
    January 17, 2013
    Report Date
    January 16, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF INCREASED CELIAC SYMPTOMS UNSPECIFIED IN (B)(6) FEMALE PT WHO USED GLUCOSE OXIDASE + LACTOPEROXIDASE + LYSOZYME (BIOTENE DRY MOUTH ORAL RINSE) FOR UNKNOWN INDICATION. A PHYSICIAN OR OTHER HLTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED CELIAC DISEASE. ON AN UNKNOWN DATE, THE PT BEGAN USING GLUCOSE OXIDASE + LACTOPEROXIDASE + LYSOZYME (UNK). AN UNK TIME LATER, THE PT EXPERIENCED AN INCREASE IN HER CELIAC DISEASE SYMPTOMS. SHE QUESTIONED WHETHER THE PRODUCT WAS GLUTEN-FREE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. BIOTENE DRY MOUTH ORAL RINSE IS MFG BY LACLEDE IN (B)(4). NEITHER THE PRODUCT NOR LOT NUMBER WAS AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25567 BIOTENE DRY MOUTH ORAL RINSE GLUC OXIDASE + LACTOPEROXIDASE + LYSOZYME LFD GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other