BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE SMOOTH

    MDR report key: 23620920 · Received November 21, 2025

    Report

    Report Number
    3003672980-2025-00157
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    June 25, 2025
    Report Date
    November 21, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    UDI-DI
    03760172161271
    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

    THE PRODUCT WAS INJECTED INTO THE PATIENT AND IS NOT AVAILABLE FOR RETURN. THE PRODUCTION RECORDS FOR THE LOT WERE REVIEWED, AND NO DEVIATIONS WERE FOUND DURING PRODUCTION THAT WOULD RELATE TO THE REPORTED EVENT; THE DEVICE MET ALL SPECIFICATIONS. INFLAMMATION SUCH AS SWELLING OR REDNESS MAY DEVELOP NEAR THE DERMAL FILLER INJECTION SITE FOLLOWING VIRAL OR BACTERIAL ILLNESSES OR INFECTIONS, VACCINATIONS, OR DENTAL PROCEDURES. IN SOME CASES, SIDE EFFECTS MAY EMERGE WEEKS, MONTHS, OR YEARS LATER. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING AND RISK MANAGEMENT FILE. THE PRODUCT WAS USED OFF-LABEL IN THE LIP REGION. WE CANNOT RULE OUT THAT THIS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. COMPLAINTS: (B)(4). CAPA: 25002.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED INJECTING 0.8ML OF EVOLYSSE SMOOTH INTO THE UPPER AND LOWER LIPS OF A PATIENT. APPROXIMATELY 8 WEEKS POST INJECTION, THE PATIENT EXPERIENCED LUMPS. THE HCP DISSOLVED THE LUMPS WITH HYALURONIDASE WITH SOME DIFFICULTY. THE MANUFACTURER PROVIDED SYRINGE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077531 EVOLYSSE SMOOTH IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE S2251050161 03760172161271

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other