BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUGARD ORAL RINSE

    MDR report key: 22510002 · Received July 15, 2025

    Report

    Report Number
    MW5172686
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    July 10, 2025
    Report Date
    July 10, 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

    EVENT: PATIENT CAREGIVER REPORTED MISSED DOSE OF MEDICATION BECAUSE OF HOSPITALIZATION AND BEING INTUBATED. FREQ. SWISH AND SWALLOW 5-10 ML BID, STARTING FIRST DAY OF RADIATION THERAPY. PRESCRIBER CONTACT INFORMATION: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151988 MUGARD ORAL RINSE ORAL WOUND DRESSING OLR SOLEVA PHARMA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Hospitalization ATORVASTATIN TAB 40MG.| FOLIC ACID TAB 400MCG.| KEPPRA TAB 250MG.| PRILOSEC OTC TAB 20MG.| TYLENOL TAB 325MG.