BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE

    MDR report key: 8301465 · Received February 1, 2019

    Report

    Report Number
    MW5083668
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    January 25, 2019
    Report Date
    January 26, 2019
    Manufacturer
    GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED BIOTENE DRY MOUTH WASH LAST NIGHT AND WOKE UP TO SWOLLEN GUMS AND THE INSIDE OF BOTH LIPS AND CHEEK. MY TONGUE WAS FINE. IT'S BEEN 24 HOURS AND IT'S STILL SWOLLEN TO A DEGREE. IS THIS PRODUCT OVER THE COUNTER? YES. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2019. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2019. I HAVE DRY MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91340 BIOTENE DRY MOUTH ORAL RINSE SALIVA, ARTIFICIAL LFD GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC 8L168C

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR