BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUGARD ORAL RINSE 240ML/BTL

    MDR report key: 23771605 · Received December 10, 2025

    Report

    Report Number
    MW5180285
    Event Type
    Injury
    Date Received
    December 10, 2025
    Report Date
    December 5, 2025
    Manufacturer
    SOLEVA PHARMA LLC
    Product Code
    OLR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    EVENT: CAREGIVER REPORTED THAT THE PATIENT IS IN THE HOSPITAL FOR DIARRHEA AND DEHYDRATION, UNSURE IF PATIENT IS NEW TO THERAPY OR NOT, THIS IS THEIR FIRST FILL WITH WSP. FREQ: RINSE MOUTH WITH 5-10ML FOR AT LEAST ONE MINUTE 4 TIMES A DAY. EXPEL QR SWALLOW AFTER RINSING. AVOID EATING QR DRINKING FOR AT LEAST 1 HOUR AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554714 MUGARD ORAL RINSE 240ML/BTL ORAL WOUND DRESSING OLR SOLEVA PHARMA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female