BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE FORM

    MDR report key: 23585522 · Received November 18, 2025

    Report

    Report Number
    3003672980-2025-00009
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    May 19, 2025
    Report Date
    November 18, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    PMA / PMN Number
    P240022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT REPORTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING AND RISK MANAGEMENT FILE. LUMPS AND BUMPS APPEARING JUST AFTER ADMINISTERING AN INJECTION IS LIKELY THE RESULT OF AN UNEVEN DISTRIBUTION OF A PRODUCT THAT HAS BEEN INJECTED TOO SUPERFICIALLY OR IN TOO LARGE A QUALITY. THE EFFECT IS TEMPORARY. THE PRODUCT WAS USED OFF-LABEL IN THE LIP REGION. WE CANNOT RULE OUT THAT THIS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. COMPLAINTS: EUS: (B)(4).

    Description of Event or Problem · 0

    THE PATIENT RECEIVED AN INJECTION OF EVOLYSSE SMOOTH INTO THE LIPS ON (B)(6) 2025. THE INITIAL PROCEDURE DID NOT ACHIEVE THE INTENDED AESTHETIC OUTCOME, AS ASYMMETRY AND DROOPING WERE OBSERVED IN THE LOWER LIP. TO ADDRESS THESE CONCERNS, 0.55CC OF EVOLYSSE FORM WAS ADMINISTERED TO THE BOTTOM LIP ON (B)(6) 2025. ON (B)(6) 2025, TWO WEEKS FOLLOWING THE SUBSEQUENT INJECTION, THE PATIENT REPORTED THE PRESENCE OF LUMPS IN THE LIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811204 EVOLYSSE FORM IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other EVOLYSSE SMOOTH ON (B)(6) 2025.