BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE SMOOTH

    MDR report key: 23214252 · Received October 3, 2025

    Report

    Report Number
    3003672980-2025-00090
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    August 8, 2025
    Report Date
    October 3, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    PMA / PMN Number
    P240022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE HEALTHCARE PROVIDER REPORTED INJECTING SMOOTH INTO THE TEMPLES OF A PATIENT. THE PATIENT EXPERIENCED LUMPS. THE LUMPS PERSISTED AND THE PRODUCT WAS DISSOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904288 EVOLYSSE SMOOTH IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other