BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE DRY MOUTH SPRAY

    MDR report key: 11260548 · Received January 29, 2021

    Report

    Report Number
    MW5099107
    Event Type
    Injury
    Date Received
    January 29, 2021
    Date of Event
    January 26, 2021
    Report Date
    January 28, 2021
    Manufacturer
    GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SWOLLEN FACE, EYELIDS FOREHEAD, HIVES ON NOSE BRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146028 BIOTENE DRY MOUTH SPRAY SALIVA, ARTIFICIAL LFD GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC U0H311

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR