BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE ORALBALANCE GEL

    MDR report key: 2163628 · Received June 10, 2011

    Report

    Report Number
    2022474-2011-00001
    Event Type
    Other
    Date Received
    June 10, 2011
    Report Date
    June 9, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BIOTENE ORALBALANCE GEL IS MANUFACTURED BY LACLEDE, INC. IN (B)(4). THE LOT NUMBER IS AVAILABLE ((B)(4)). IT IS UNK IF THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF HOARSE VOICE IN A (B)(6) FEMALE PT WHO RECEIVED GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME (BIOTENE ORALBALANCE GEL) FOR DENTAL CARE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME (DENTAL). AT AN UNK TIME AFTER STARTING GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME, THE PT EXPERIENCED HOARSE VOICE, FEELING UNWELL, POSSIBLE STROKE, COUGH AND CANNOT CATCH BREATH. THE CONSUMER STATED THAT SHE USED THE PRODUCT FOR A COUPLE OF DAYS AND EXPERIENCED HOARSE VOICE, DIDN'T FEEL WELL, COUGH AND UNABLE TO CATCH BREATH. THE CONSUMER ALSO REPORTED "I FELT THAT I MIGHT HAVE HAD A STROKE." THE CONSUMER REPORTED THAT SHE INITIALLY WENT TO "EMERGENCY" WHEN SHE WAS FEELING AS THOUGH SHE MIGHT HAVE HAD A STROKE AND THEN CLARIFIED THAT SHE HAD GONE TO THE LOCAL FIRE STATION. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. CONSUMER REPORTED HOARSENESS CONTINUES. CONSUMER REPORTED POSSIBLE STROKE STATING SHE "FELT THAT SHE MIGHT HAVE HAD A STROKE OR SOMETHING." CONSUMER REPORTED DIDN'T FEEL WELL AND POSSIBLE STROKE HAVE RESOLVED. CONSUMER REPORTED COUGH AS IMPROVED, STATING THE EVENT IS OCCURRING LESS FREQUENTLY, AND CONSUMER REPORTED CANNOT CATCH BREATH HAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTENE ORALBALANCE GEL GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXID KOO GLAXOSMITHKLINE NA 1A1302

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other