BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE SMOOTH

    MDR report key: 23295378 · Received October 15, 2025

    Report

    Report Number
    3015260155-2025-00098
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 19, 2025
    Report Date
    October 14, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, 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 0.5ML OF EVOLYSSE SMOOTH INTO THE LIPS OF A PATIENT. THE HCP ASPIRATED PRIOR TO INJECTING AND UPON WITHDRAWING THE NEEDLE PATIENT IMMEDIATELY DEVELOPED SWELLING AND DISCOLORATION ON THE RIGHT LOWER LIP CONSISTENT AT THE INJECTION SITE. PATIENT EXPERIENCED PAIN TO THE INJECTION SITE WHICH RADIATED TO THE RIGH CHEEK AND CHIN. HCP TREATED WITH THE PATIENT WITH 3 VIALS OF HYLENEX, MASSAGING THE AREA, AND GAVE THE PATIENT AN ORAL BABY ASPRIN. THE PATIENT WAS TREATED WITH HYALURONIDASE, MASSAGE, AND ORAL ASPIRIN. PATIENT BEGAN EXPERIENCING SYMPTOMS OF SYNCOPE AND WAS TRANSPORTED TO THE EMERGENCY ROOM. AT THE ER AN ULTRASOUND WAS USED TO ASSESS THE BLOOD SUPPLY WHICH CONFIRMED A VASCULAR OCCLUSION. THE PATIENT WAS TREATED WITH 3 MORE VIALS OF HYLENEX, IV MORPHINE, TRAMADOL, 1G OF VALCYCLOVIR. PATIENT WAS DISCHARGED THE SAME DAY ON THE FOLLOWING PROTOCOL: DOXYCICLINE 100MG BIDX 7 DAYS, VALCYCLOVIR 500G BIDX5DAYS, PREDNISONE 20MG DAILY X 5 DAYS, AND ASPRIN DAILY X 7 DAYS. AS OF (B)(6) 2025 IT WAS REPORTED THE PATIENT IS FEELING MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004167 EVOLYSSE SMOOTH IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE S2250560162

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Required Intervention