BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUGARD ORAL RINSE

    MDR report key: 22914181 · Received August 28, 2025

    Report

    Report Number
    MW5175343
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 9, 2025
    Report Date
    August 25, 2025
    Manufacturer
    SOLEVA PHARMA LLC
    Product Code
    OLR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS HOSPITALIZED FOR DEHYDRATION AND THE PATIENT HAD TO HAVE A FEEDING TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834667 MUGARD ORAL RINSE ORAL WOUND DRESSING OLR SOLEVA PHARMA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Hospitalization CLARITIN TAB 10MG.| HYDROCO/APAP TAB 7.5-325.| IBUPROFEN DRO 50/1.25.| SWISH 5 ML.| TAMSULOSIN CAP 0.4MG.