MAUDE Adverse Event Report: SYMATESE EVOLYSSE SMOOTH; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	EVO-SMTH-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The healthcare provider reported injecting a patient with evolysse smooth in and around the lips, perioral lines, and brows.Approximately one (1) week post injection, the patient experienced induration and swelling/inflammation at all injection sites.The hcp treated the induration with 30 units of hyaluronidase in areas of injection swelling/iriritation; however, the infammation/swelling persisted.
Additional Manufacturer Narrative
The filler was injected into the patient and is not available for return.The event is a physiological event complication and analysis of the device does not assist in determining a probable cause of the event.This is a known potential adverse event addressed in the product labeling.[eus-20250930-949][2] and 3354.

• Brand Name: EVOLYSSE SMOOTH
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): SYMATESE; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• Manufacturer (Section G): SYMATESE; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• Manufacturer Contact: laurence hermitte ; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• MDR Report Key: 23441953
• Report Number: 3003672980-2025-00125
• Device Sequence Number: 8552310
• Product Code: LMH
• UDI-Device Identifier: 03760172161271
• UDI-Public: (01)03760172161271(17)20270331(10)S2251220015
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P240022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EVO-SMTH-01
• Device Lot Number: S2251220015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female