BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE FORM

    MDR report key: 23097530 · Received September 19, 2025

    Report

    Report Number
    3003672980-2025-00062
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 11, 2025
    Report Date
    February 25, 2026
    Manufacturer
    SYMATESE
    Product Code
    LMH
    UDI-DI
    03760172161264
    PMA / PMN Number
    P240022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP 1: DURING AN MDR RECONCILIATION AGAINST THE FDA MAUDE DATABASE, IT WAS DISCOVERED THAT THIS REPORT IS A DUPLICATE. REFERENCE REPORT 3003672980-2025-00134 FOR FUTURE UPDATES. (B)(4).

    Additional Manufacturer Narrative · 0

    FILLERS WERE INJECTED INTO THE PATIENT AND IS NOT AVAILABLE FOR RETURN. THE EVENT IS A PHYSIOLOGICAL EVENT COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST IN DETERMINING A PROBABLE CAUSE OF THE EVENT. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL INJECTED 1 SYRINGE OF EVOLYSSE FORM INTO A PATIENT VIA A NEEDLE TO THE PERIOSTEUM UNDER THE EYES ALONG THE ORBITAL RIM WITH THE PROVIDED NEEDLE. APPROXIMATELY THREE (3) DAYS POST INJECTION ON (B)(6) 2025, THE PATIENT DEVELOPED LUMPS IN THE TEAR TROUGHS AND TYNDALL EFFECT. AFTER WAITING ONE (1) MONTH, THE PRODUCT WAS DISSOLVED AND THE PATIENT'S SYMPTOMS RESOLVED. 25-FEB-2026 FOLLOW UP: DURING AN MDR RECONCILIATION AGAINST THE FDA MAUDE DATABASE, IT WAS DISCOVERED THAT THIS REPORT IS A DUPLICATE. REFERENCE REPORT 3003672980-2025-00134 FOR FUTURE UPDATES.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1 SYRINGE OF EVOLYSSE FORM VIA PROVIDED NEEDLE IN THE PERIOSTEUM UNDER EYES ALONG THE ORBITAL RIM. THE HCP ALSO REPORTED PLACING A CANNULA DOWN TO THE PERIOSTEUM AND SUBDERMAL FACE FOR INJECTION OF PRODUCT. THE PATIENT EXPERIENCED LUMPS IN THE TEAR TROUGHS AND TYNDALL EFFECT. AFTER ONE (1) MONTH FOLLOWING THE INJECTION, THE PRODUCT WAS DISSOLVED NO FURTHER ACTION IS NEEDED. ADDITIONAL COMMENTS: IMPORTER COMPLAINT NUMBER (B)(4), SAFETY DATABASE REFERENCE NUMBER (B)(4). THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556205 EVOLYSSE FORM IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE S2250920012 03760172161264

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Other 2 SYRINGES OF EVOLYSSE SMOOTH INJECTED.