BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE ORALBALANCE GEL

    MDR report key: 1572609 · Received January 7, 2010

    Report

    Report Number
    2022474-2010-00001
    Event Type
    Other
    Date Received
    January 7, 2010
    Report Date
    January 6, 2010
    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 VISION LOSS IN A (B)(6) FEMALE PT WHO RECEIVED GLUCOSE OXIDASE + LACTOFERRIN + LACTOPEROXIDASE + LYSOZYME (BIOTENE ORALBALANCE GEL) GEL FOR AN UNK INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT BEGAN USING BIOTENE ORALBALANCE GEL AT UNK DOSING. AN UNK TIME LATER, THE PT EXPERIENCED VISION LOSS, NAUSEA, DEHYDRATION, APPETITE LOSS, DIARRHEA, STOMACH PAIN, METALLIC TASTE, BURNING WITH BOWEL MOVEMENT, BURNING SENSATION IN EYE, FOG IN FRONT OF EYES AND BURNING SENSATION OF EYELID. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH BIOTENE ORALBALANCE GEL DISCONTINUED. AT THE TIME OF REPORTING THE VISION LOSS WAS UNRESOLVED, AND THE OTHER EVENTS WERE RESOLVED. MFR'S COMMENT: THE MFR'S REPORT NUMBER FOR THIS CASE IS 2022474-2010-00001. BIOTENE ORALBALANCE GEL IS MFG BY LACLEDE, INC IN (B)(4). NEITHER THE LOT NUMBER OR PRODUCT WAS AVAILABLE. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTENE ORALBALANCE GEL DRY MOUTH GEL LFD GLAXOSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other