BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE DRY MOUTH

    MDR report key: 8912182 · Received August 19, 2019

    Report

    Report Number
    MW5089176
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    August 13, 2019
    Report Date
    August 15, 2019
    Manufacturer
    GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I SPRAYED BIOTENE SPRAY INTO MY MOUTH AND THEN I COULDN'T BREATHE. MY THROAT SWELLED, MY CHEST STARTED BURNING, SWEAT WAS POURING OUT AND I WAS COUGHING SO HARD, I ALMOST VOMITED. I WAS TRYING TO DIAL 911 BUT DROPPED THE PHONE UNDER THE BED. AFTER ABOUT 10 MINS, IT WAS A LITTLE BETTER. I COUGHED HARD ALL NIGHT LONG. I AM STILL COUGHING UP MUCUS. TRYING TO GET DOCTOR APPT. GIVE BEST ESTIMATE OF DURATION: 1 YEAR. REASON FOR USE: DRY MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698814 BIOTENE DRY MOUTH SALIVA, ARTIFICIAL LFD GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC U9J251/U8J251

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening