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

Catalog Number	EVO-SMTH-01
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pain (1994); Obstruction/Occlusion (2422); Pallor (2468)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The filler was injected into the patient and is not available for return.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.Additionally, the product was used off-label in the lip region.We cannot rule out that this may have contributed to the reported event.The batch release form was reviewed, and the device met all specifications prior to release.Eus-(b)(4).
Event or Problem Description
On (b)(6) 2026, the hcp reported injecting 0.4cc of evolysse smooth into the lips of a patient by backfilling the product into a bd syringe.Immediately following the injection, the patient experienced blanching and pain at the wet/dry border along with significant bruising.The hcp determined the symptoms to be consistent with a vascular occlusion and injected the patient's lips with 1 vial of hylenex over three (3) injections.The aforementioned treatment was successful in treating the vascular occlusion.As of (b)(6) 2026, all the patient's symptoms have resolved; no long term effects were reported.

• 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: 24670476
• Report Number: 3015260155-2026-00006
• Device Sequence Number: 5032452
• Product Code: LMH
• UDI-Device Identifier: 03760172161271
• UDI-Public: (01)03760172161271(17)270331(10)S2251220015
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/23/2026
• Report Date (Section F): 03/23/2026

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?: Yes
• Distributor Facility Aware Date: 05/05/2026
• Event Location: Other
• Date Report to Manufacturer: 03/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2026
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/23/2026