BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE SMOOTH

    MDR report key: 24967511 · Received April 23, 2026

    Report

    Report Number
    3015260155-2026-00009
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 23, 2026
    Manufacturer
    SYMATESE
    Product Code
    LMH
    UDI-DI
    03760172161271
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT AVAILABLE FOR RETURN. THE BATCH RELEASE FORM WAS REVIEWED AND THE DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE. BASED ON THE REPORTED INFORMATION, THIS EVENT IS CONSISTENT WITH A VASCULAR OCCLUSION WHICH IS A KNOWN SERIOUS ADVERSE EVENT DOCUMENTED IN THE LABELING. THIS CAN OCCUR DUE TO UNINTENDED INJECTION INTO A BLOOD VESSEL OR INJECTION OF A LARGE AMOUNT OF FILLER NEAR A BLOOD VESSEL CAUSING COMPRESSION OF THE BLOOD VESSEL. BOTH OCCLUSION AND COMPRESSION MAY RESULT IN REDUCED OR CESSATION OF BLOOD SUPPLY TO TISSUES. INTERVENTION IS REQUIRED TO PREVENT SERIOUS AND PERMANENT COMPLICATIONS. (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2026 A HEALTHCARE PROVIDER REPORTED INJECTING 0.6 CC OF EVOLYSSE SMOOTH INTO A FEMALE PATIENT IN THE LIPS USING A SUPERFICIAL, LINEAR THREADING TECHNIQUE WITH A 30 GAUGE NEEDLE. THE PATIENT EXPERIENCED SLIGHT BLANCHING IN THE UPPER RIGHT LIP TISSUE ALONG WITH A HEMATOMA. TREATMENT WITH ICE AND ARNICA WERE ADMINISTERED PRIOR TO THE PATIENT LEAVING THE OFFICE. THE SAME DAY AS THE INJECTION, AT APPROXIMATELY 8:30 PM, THE PATIENT NOTIFIED THE INJECTING PHYSICIAN AND REPORTED PAIN AND DISCOLORATION IN THE UPPER LIP AND PERIORAL AREA. THE PATIENT RETURNED TO THE OFFICE IMMEDIATELY AND A VASCULAR OCCLUSION WAS CONFIRMED BY THE HCP. SYMPTOMS INCLUDED DELAYED CAPILLARY REFILL, PAIN AND TISSUE BLANCHING. HEAT AND MASSAGE TO THE AFFECTED AREA WAS PERFORMED AND THE PATIENT WAS INJECTED WITH 2 VIALS OF HYLENEX. FOLLOWING TREATMENT, THE HCP OBSERVED THE SKIN COLOR AND CAPILLARY REFILL RETURNED TO NORMAL. THE PATIENT RETURNED HOME. ON THE (B)(6) 2026 THE PATIENT REPORTED HER SYMPTOMS HAD RETURNED AND A BLISTER HAD FORMED ON THE UPPER LIP. THE PATIENT WAS SENT FOR AN ULTRASOUND. THE HCP STATED THE ULTRASOUND SHOWED THE VASCULAR OCCLUSION WAS NOT FULLY RESOLVED. THE HCP INJECTED THE UPPER LIP WITH 2 ADDITIONAL VIALS OF HYLENEX. THE HCP CONTINUED THE VASCULAR OCCLUSION PROTOCOL OF HEAT AND VIGOROUS MASSAGE FOR THE NEXT FEW HOURS UNTIL THE TISSUE RETURNED TO NORMAL. THE PATIENT UNDERWENT TWO HYPERBARIC OXYGEN TREATMENTS FOLLOWING WHICH THE HCP REPORTED A FULL RESOLUTION OF THE VASCULAR OCCLUSION WITH TISSUE FULLY PERFUSED, PINK AND CAPILLARY REFILL RETURNED TO NORMAL. THE BLISTER IS SCABBING AND HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248948 EVOLYSSE SMOOTH IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE S2252450013 03760172161271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention