BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE SMOOTH

    MDR report key: 23415739 · Received October 29, 2025

    Report

    Report Number
    3003672980-2025-00129
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    August 22, 2025
    Report Date
    October 29, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    UDI-DI
    03760172161271
    PMA / PMN Number
    P240022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT AVAILABLE FOR RETURN. THE EVENT IS A PHYSIOLOGICAL EVENT COMPLICATION AND ANALYSIS OF THE DEVICE DOES NOT ASSIST IN DETERMINING A PROBABLE CAUSE OF THE EVENT. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. COMPLAINT (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 0.3CC OF EVOLYSSE SMOOTH INTO THE SMILE LINES, CHEEKS, AND PERIORAL LINES. APPROXIMATELY TWO (2) WEEKS POST INJECTION, THE PATIENT EXPERIENCED VISIBLE LUMPS/NODULES IN THE LEFT CHEEK. THE HCP RECOMMENDED MASSAGE. PATIENT DECLINED TO HAVE PRODUCT DISSOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214204 EVOLYSSE SMOOTH IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE S2251220015 03760172161271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other