BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE FORM

    MDR report key: 23238409 · Received October 7, 2025

    Report

    Report Number
    3015260155-2025-00089
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    July 23, 2025
    Report Date
    October 7, 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

    Description of Event or Problem · 0

    THE HEALTHCARE PROVIDER REPORTED INJECTING 1CC OF EVOLYSSE FORM INTO THE LIPS AND MARIONETTE LINES OF A PATIENT. THE PATIENT EXPERIENCED HARD LUMPS AROUND THE MOUTH AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2767014 EVOLYSSE FORM IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE S2251120201

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female EVOLYSSE SMOOTH.