BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE SMOOTH

    MDR report key: 23268430 · Received October 10, 2025

    Report

    Report Number
    3015260155-2025-00096
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 10, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED INJEJCTING 0.5ML OF EVOLYSSE SMOOTH INTO THE MARIONETTE LINES OF A PATIENT VIA 25G 1.5" DERMASCULPT CANNULA. PATIENT COMPLAINED OF DISCOMFORT AND PAIN WITHIN THE GUMS NEAR LOWER TEETH. PATIENT WAS OBSERVED TO HAVE BRUSING AND VISIBLE LUMPS AND TRACKS OF PRODUCT IN THE ORAL MUCOSA OF THE LOWER LIP. THE HCP DISSOLVED THE PRODUCT WITH 150 UNITS OF HYLENEX. PATIENT'S DISCOMFORT WAS RESOLVED IMMEDIATELY. THE PATIENT HAS BRUSING FOLLOWING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282063 EVOLYSSE SMOOTH IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE S2251530008

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other