BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE SMOOTH

    MDR report key: 22506254 · Received July 15, 2025

    Report

    Report Number
    3015260155-2025-00005
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 11, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BUMPS [INJECTION SITE MASS], BRUISES [ INJECTION SITE BRUISING], OFF LABEL USE IN OTHER AREA [OFF LABEL USE OF DEVICE]. THIS REPORT FROM THE UNITED STATES WAS REPORTED BY A HEALTHCARE PROFESSIONAL VIA COMPANY REPRESENTATIVE ON 16-JUN-2025 AND CONCERNS A 30-YEAR-OLD PATIENT OF UNKNOWN GENDER WHO EXPERIENCED BUMPS AND BRUISES COINCIDENT WITH EVOLYSSE SMOOTH. ON (B)(6) 2025, THE INJECTOR ADMINISTERED SMOOTH (DOSE AND INDICATION UNKNOWN), AND ON (B)(6) 2025 THE PATIENT EXPERIENCED BUMPS AND BRUISES. THE HEALTHCARE PROFESSIONAL STATED THAT SHE HAD NEVER ENCOUNTERED LUMPS AND LARGE BRUISING WITH OTHER FILLERS BEFORE. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. AT THE TIME OF THE REPORT, THE OUTCOME OF THE BUMPS AND BRUISES WAS UNKNOWN. COMPANY COMMENT: INVESTIGATION IN PROGRESS. DATABASE REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128071 EVOLYSSE SMOOTH Implant, dermal, for aesthetic use LMH SYMATESE

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown Other