BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE ORALBALANCE GEL

    MDR report key: 2222848 · Received August 9, 2011

    Report

    Report Number
    2022474-2011-00003
    Event Type
    Other
    Date Received
    August 9, 2011
    Report Date
    August 8, 2011
    Manufacturer
    LACLEDE, INC.
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A0939523A.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER (WIFE OF PT) AND DESCRIBED THE OCCURRENCE OF THYROID NEOPLASM IN A MALE PT WHO RECEIVED GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME (BIOTENE ORALBALANCE GEL) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME (BIOTENE MOUTHWASH). ON AN UNK DATE, THE PT STARTED THE FORMULATIONS OF GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME. AT AN UNK TIME AFTER STARTING GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME, THE PT EXPERIENCED THYROID NEOPLASM. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED. THE REPORTER DID NOT WISH TO PROVIDE CONTACT INFO; THEREFORE, THIS CASE IS LOST TO F/U. BIOTENE IS MANUFACTURED IN (B)(4) IN THE UNITED STATES AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTENE ORALBALANCE GEL ORAL GEL LFD LACLEDE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other