BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE MOISTURIZING MOUTH SPRAY

    MDR report key: 2413038 · Received January 6, 2012

    Report

    Report Number
    2022474-2012-00001
    Event Type
    Other
    Date Received
    January 6, 2012
    Report Date
    January 5, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER REPORTED SHE HAD AN ALLERGIC REACTION TO THE EGG IN BOTH THE BIOTENE SPRAY AND GEL SHE WAS USING WHICH CAUSED HER TO HAVE AN "ANAPHYLACTIC ATTACK". THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS (B)(4). BIOTENE MOISTURIZING MOUTH SPRAY IS MANUFACTURED BY LACLEDE, INC IN (B)(4). WHILE THE LOT NUMBER IS AVAILABLE. IT IS UNK WHETHER 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 DIFFICULTY BREATHING IN A (B)(6) FEMALE PT WHO RECEIVED LACTOPEROXIDASE + LYSOZYME (BIOTENE MOISTURIZING MOUTH SPRAY) 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 ORALBALANCE GEL). ON AN UNK DATE, THE PT STARTED LACTOPEROXIDASE + LYSOZYME AND GLUCOSE OXIDASE + LACTOFERRIN + LACTOPEROXIDASE + LYSOZYME. AT AN UNK TIME AFTER STARTING LACTOPEROXIDASE + LYSOZYME AND GLUCOSE OXIDASE + LACTOFERRIN + LACTOPEROXIDASE + LYSOZYME, THE PT EXPERIENCED DIFFICULTY BREATHING, SWOLLEN TONGUE, ANAPHYLACTIC REACTION, TROUBLE SPEAKING, ALLERGIC REACTION AND WHEEZING. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. THE PT WAS TREATED WITH SALBUTAMOL SULPHATE (ALBUTEROL) AND ADRENALINE (EPIPEN). TREATMENT WITH LACTOPEROXIDASE + LYSOZYME AND GLUCOSE OXIDASE + LACTOFERRIN + LACTOPEROXIDASE = LYSOZYME WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTENE MOISTURIZING MOUTH SPRAY LACTOPEROXIDASE + LYSOZYME LFD GLAXOSMITHKLINE NA 1E23C1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other