BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUGARD ORAL RINSE 240ML/BTL

    MDR report key: 20075842 · Received August 23, 2024

    Report

    Report Number
    MW5158802
    Event Type
    Injury
    Date Received
    August 23, 2024
    Report Date
    August 21, 2024
    Manufacturer
    SOLEVA PHARMA LLC
    Product Code
    MGQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT: PT REPORTED HE IS CURRENTLY HOSPITALIZED FOR AN UNSPECIFIED REASON AND WILL BE GETTING A FEEDING TUBE IN HIS STOMACH. FREQ: SWISH AND EXPEL OR SWALLOW 5 TO 10 ML 4-6 TIMES DAILY AS PRESCRIBED FOR THE MANAGEMENT OF ORAL MUCOSITIS. PRESCRIBER INFO: (B)(6). PH: (B)(6), FAX: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465555 MUGARD ORAL RINSE 240ML/BTL DRESSIN, WOUND AND BURN, HYDROGELW/DRUG AND/OR BIOLOGIC MGQ SOLEVA PHARMA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization