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

Catalog Number	EVO-SMTH-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported injecting a patient with 1.0cc of evolysse smooth into the smile lines, cheeks, and perioral lines.Approximately one (1) week post injection, the patient experienced visible lumps in the left cheek.The hcp recommended massage.On (b)(6) 2025, the patient still had noticeable lumps present.Hcp treated patient with approximately 15 units of hylenex and successfully dissolved the lump.
Additional Manufacturer Narrative
(b)(4).

• 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
• MDR Report Key: 23408409
• Report Number: 3015260155-2025-00104
• Device Sequence Number: 8727645
• Product Code: LMH
• UDI-Device Identifier: 03760172161271
• UDI-Public: (01)03760172161271(17)20270331(10)S2251220015
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025
• Report Date (Section F): 09/29/2025

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/29/2025
• Event Location: Other
• Date Report to Manufacturer: 09/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female