BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE SMOOTH

    MDR report key: 23204669 · Received October 2, 2025

    Report

    Report Number
    3015260155-2025-00090
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    August 7, 2025
    Report Date
    October 2, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED INJECTING EVOLYSSE SMOOTH INTO THE TEMPLES OF A PATIENT. APPROXIMATELY ONE (1) MONTH POST INJECTION, THE PATIENT HAD LUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313322 EVOLYSSE SMOOTH IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other