BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE SMOOTH

    MDR report key: 23204647 · Received October 2, 2025

    Report

    Report Number
    3015260155-2025-00085
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    July 10, 2025
    Report Date
    October 2, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED INJECTING LESS THAN A SYRINGE OF SMOOTH INTO THE LIPS, CHIN, MARIONETTE LINES, AND PERIORAL LINES OF A PATIENT. TWO DAYS POST INJECTION PATIENT REPORTED PAIN AND LUMPS ON THE FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318115 EVOLYSSE SMOOTH IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE S2251050161

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other EVOLYSSE FORM.