BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE

    MDR report key: 6875891 · Received September 18, 2017

    Report

    Report Number
    MW5072195
    Event Type
    Injury
    Date Received
    September 18, 2017
    Date of Event
    August 18, 2017
    Report Date
    September 16, 2017
    Manufacturer
    GSK CONSUMER HEALTHCARE
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER USING BIOTENE FOR APPROX 2 WEEKS, I COULD NOT SWALLOW FOOD AT LUNCH WITH A FELLOW PROJECT MANAGER. THE FOOD WAS STUCK IN MY THROAT. HE WAS ABOUT TO GIVE ME HYMLICK. AFTER STANDING THE FOOD RELEASED, I WAS TOLD TO USE THIS PRODUCT WHILE HAVING DRY MOUTH FROM TAKING CHLORTHALIDONE AND HAVING SOME DENTAL WORK DONE. I ALSO USE THE SPRAY TYPE DURING THE DAY. I SAW AN ENT ABOUT THIS SWALLOWING PROBLEM. DR (B)(6). HE STATED THE ESOPHAGUS WAS SWOLLEN. AND I HAD A SMALL CYST CLOSE TO THE OPENING. "IS THE PRODUCT OVER-THE-COUNTER: YES." DATES OF USE: (B)(6) 2017. THE PROBLEM DID NOT STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT. DRY MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651919 BIOTENE BIOTENE LFD GSK CONSUMER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening