BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE ORAL RINSE

    MDR report key: 3338749 · Received August 27, 2013

    Report

    Report Number
    1718912-2013-00015
    Event Type
    Other
    Date Received
    August 27, 2013
    Report Date
    August 26, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S REPORT NUMBER FOR THIS CASE IS 1718912-2013-00015. BIOTENE ORAL RINSE IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4)

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF EXACERBATION OF MACULAR DEGENERATION IN A (B)(6) FEMALE PT WHO RECEIVED ORAL MOISTURISERS (BIOTENE ORAL RINSE) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED CATARACT, DRY MOUTH, MACULAR DEGENERATION AND PERIODONTAL POCKET. CONCURRENT MEDICATIONS INCLUDED GARLIC, CAROTENOIDS (LUTEIN),ZINC SALT (ZINC), MINERAL SUPPLEMENTS (MINERALS) AND MULTIVITAMINS (VITAMINS). ON AN UNK DATE, THE PT STARTED ORAL MOISTURISERS (SINGLE DOSE). ON AN UNK DATE, EXPERIENCED EXACERBATION OF MACULAR DEGENERATION, CATARACT AGGRAVATED, ABNORMAL VISION, BLURRED VISION AND CONDITION AGGRAVATED. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. THE PT WAS TREATED WITH NUTRITIONAL INGREDIENT(S) NOT REFERENCED ("NUTRITIONAL HEALING"). TREATMENT WITH ORAL MOISTURISERS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED. CONSUMER REPORTED THAT SHE TRIED BIOTENE DRY MOUTH ORAL RINSE ONCE 6 MONTHS AGO AND IT AFFECTED HER EYESIGHT. CONSUMER REPORTED THAT PRIOR TO USING BIOTENE DRY MOUTH ORAL RINSE, SHE HAD CATARACT AND MACULAR DEGENERATION AND BIOTENE DRY MOUTH ORAL RINSE MADE HER VISION BLURRY, AFFECTED HER EYE SIGHT AND MADE HER CONDITIONS OF CATARACT AND MACULAR DEGENERATION WORSE. CONSUMER REPORTED THE EXPERIENCES OF AFFECTED EYESIGHT, BLURRY VISION, CATARACT AND MACULAR DEGENERATION HAVE RESOLVED AND HAVE BEEN HEALED BY NUTRITIONAL HEALING. CONSUMER USES VITAMINS, MINERALS AND HERBS FOR EACH CONDITION SHE HAS AND IT WORKS EACH TIME. CONSUMER IS GOING TO BEGIN USING BIOTENE ORIGINAL TOOTHPASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418262 BIOTENE ORAL RINSE ORAL MOISTURISERS LFD GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other LUTEIN| VITAMINS| GARLIC| GARLIC| ZINC