BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE SMOOTH

    MDR report key: 23190497 · Received October 1, 2025

    Report

    Report Number
    3003672980-2025-00077
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    June 6, 2025
    Report Date
    October 1, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    PMA / PMN Number
    P240022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMPORTER COMPLAINT NUMBER (B)(4). MANUFACTURER COMPLAINT NUMBER (B)(4). AS THE PRODUCT WAS INJECTED INTO THE PATIENT, IT IS NOT AVAILABLE FOR RETURN. ADDITIONAL ATTEMPTS TO RETRIEVE THE LOT NUMBER HAVE BEEN MADE; IF RETRIEVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED FOLLOWING BEING INJECTED WITH SMOOTH IN THE LIPS, MARIONETTE LINES, MENTAL CREASE, NASOLABIAL FOLDS, AND MIDFACE. WITHIN 48 HOURS THE PATIENT EXPERIENCED SWELLING WHICH WAS TREATED WITH BENADRYL, PEPCID, AND PREDNISONE. THEN 2 MONTHS AND 17 DAYS POST INJECTION THE PATIENT EXPERIENCED LUMPS ON THE LIPS. PATIENT VISITED HCP ON (B)(6) 2025, THAT ADVISED WAITING UNTIL THE PRODUCT IS "OUT OF THE SYSTEM." THE LIPS ARE DISCOLORED, PAINFUL, AND SWELLING HAS SPREAD OVER THE WHOLE FACE. THE PRODUCT WAS LATER DISSOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216547 EVOLYSSE SMOOTH IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention EVOLYSSE FORM.