BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE SMOOTH

    MDR report key: 23003985 · Received September 9, 2025

    Report

    Report Number
    3015260155-2025-00047
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    June 24, 2025
    Report Date
    September 5, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED FOLLOWING INJECTION OF EVOLYSSE SMOOTH IN THE PATIENT'S CHIN, MARIONETTE LINES, NASOLABIAL FOLDS, ORAL COMMISSURES AND PERIORAL LINES ON (B)(6) 2025, THE PATIENT COMPLAINED THAT IT FELT FIRM BEGINNING ON (B)(6) 2025. SAFETY DATABASE REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2466893 EVOLYSSE SMOOTH IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE S2250780085, S2250780083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other