BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE FORM

    MDR report key: 23258260 · Received October 9, 2025

    Report

    Report Number
    3003672980-2025-00082
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    July 8, 2025
    Report Date
    October 9, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    PMA / PMN Number
    P240022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED EVENT DESCRIPTION AND PRODUCT INFORMATION FROM SMOOTH TO FORM FROM THE IMPORTER'S REPORT. 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 NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED INJECTING LESS THAN ONE SYRINGE OF FORM INTO THE LIPS AND MARIONETTE LINES OF A PATIENT. IMMEDIATELY FOLLOWING THE INJECTION, THE PATIENT HAD VERY HARD, PAINFUL LUMPS. THE LUMPS WERE TREATED WITH FOUR (4) PROCEDURES TO DISSOLVE THE PRODUCT. THERE WERE NO SIGNS OF VASCULAR OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047069 EVOLYSSE FORM IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE S2251120201

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other EVOLYSSE SMOOTH.