BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE FORM

    MDR report key: 23211245 · Received October 3, 2025

    Report

    Report Number
    3003672980-2025-00095
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    August 27, 2025
    Report Date
    October 3, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    PMA / PMN Number
    P240022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT AN ADVERSE EVENT DID NOT OCCUR. COMPLAINT NUMBERS: (B)(4). 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.

    Description of Event or Problem · 0

    THE HEALTHCARE PROVIDER REPORTED INJECTING 1CC OF EVOLYSSE FORM INTO THE LIPS OF A PATIENT. THE PATIENT WAS INITIALLY REPORTED TO HAVE NODULES AND LUMP IN THE LIPS FOLLOWING INJECTION. UPON FURTHER FOLLOW-UP WITH THE HCP, THE PATIENT DID NOT EXPERIENCE NODULES AND FELT THAT THE PRODUCT HAD BEEN PLACED TOO SUPERFICIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744533 EVOLYSSE FORM IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE S2251130227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other