BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLYSSE SMOOTH

    MDR report key: 23633737 · Received November 24, 2025

    Report

    Report Number
    3015260155-2025-00127
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    August 25, 2025
    Report Date
    November 25, 2025
    Manufacturer
    SYMATESE
    Product Code
    LMH
    UDI-DI
    03760172161264
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OR, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT AVAILABLE FOR RETURN. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. THE INVESTIGATION IS ON-GOING; ANY NEW, CHANGED OR UPDATED INFORMATION WILL BE INCLUDED IN THE CORRESPONDING MANUFACTURER'S REPORT. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING AND RISK MANAGEMENT FILE. AS WITH ALL TRANSCUTANEOUS PROCEDURES, SOFT TISSUE FILLER IMPLANTATION CARRIES A RISK OF INFECTION. THE PATIENT WAS EXPOSED TO IMPETIGO FROM A CLOSE FAMILY MEMBER WHICH COULD BE A CONTRIBUTING FACTOR TO THE OUTBREAK. ADDITIONALLY, THE PRODUCT WAS USED OFF-LABEL IN THE LIP REGION. WE CANNOT RULE OUT THAT THESE FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. COMPLAINTS: (B)(4).

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL (HCP) REPORTED ADMINISTERING A DENTAL BLOCK WITH LIDOCAINE, CLEANSING THE LIPS WITH PRUMYCIN TOPICAL CLEANSER, AND THEN INJECTING LESS THAN ONE SYRINGE OF EVOLYSSE SMOOTH INTO THE LIPS OF THE PATIENT ON (B)(6) 2025. ON (B)(6) 2025 THE PATIENT EXPERIENCED BLISTERS ON THE LOWER LIP FOLLOWING CONTACT WITH A FAMILY MEMBER THAT ALSO HAD LIP BLISTERS, UPON RETURN FROM PUERTO RICO. THE PATIENT TESTED POSITIVE FOR IMPETIGO AND WAS TREATED WITH ANTIBIOTICS BY PRIMARY CARE PHYSICIAN. ON (B)(6) 2025, THE PATIENT EXPERIENCED A FIRM LUMP TO THE LEFT SIDE OF HER UPPER LIP. NO PAIN, REDNESS, OR DISCOLORATION WAS OBSERVED. THE PATIENT SELF MEDICATED WITH CLARITIN; NO IMPROVEMENT IN SYMPTOMS. A SEPARATE HCP PRESCRIBED A MEDROL PACK, ZYRTEC, AND FAMOTIDINE; PATIENT STARTED THIS TREATMENT REGIMEN ON (B)(6) 2025. THE PATIENT EXPERIENCED A FULL RESOLUTION OF SYMPTOMS UNTIL COMPLETION OF THE TREATMENT REGIMEN, THEN THE SYMPTOMS RETURNED. ON (B)(6) 2025; THE PRODUCT WAS DISSOLVED WITH 1 VIAL OF HYLENEX TO THE UPPER AND LOWER LIPS FOLLOWING ADMINISTRATION OF A LIDOCAINE NUMBING BLOCK; A SUBSEQUENT TREATMENT WITH HYLENEX WAS PERFORMED ON (B)(6) 2025. THE SYMPTOMS PERSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2749069 EVOLYSSE SMOOTH IMPLANT, DERMAL, FOR AESTHETIC USE LMH SYMATESE S2250900177 03760172161264

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other BUPROPION 150MG QD FOR DEPRESSION| ESCITALOPRAM 10MG QD FOR DEPRESSION| SPIRONOLACTONE 50MG QD FOR CYSTIC ACNE