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	Hematoma (1884); Pain (1994); Skin Discoloration (2074); Obstruction/Occlusion (2422); Pallor (2468); Blister (4537)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026 a healthcare provider reported injecting 0.6 cc of evolysse smooth into a female patient in the lips using a superficial, linear threading technique with a 30 gauge needle.The patient experienced slight blanching in the upper right lip tissue along with a hematoma.Treatment with ice and arnica were administered prior to the patient leaving the office.The same day as the injection, at approximately 8:30 pm, the patient notified the injecting physician and reported pain and discoloration in the upper lip and perioral area.The patient returned to the office immediately and a vascular occlusion was confirmed by the hcp.Symptoms included delayed capillary refill, pain and tissue blanching.Heat and massage to the affected area was performed and the patient was injected with 2 vials of hylenex.Following treatment, the hcp observed the skin color and capillary refill returned to normal.The patient returned home.On the (b)(6) 2026 the patient reported her symptoms had returned and a blister had formed on the upper lip.The patient was sent for an ultrasound.The hcp stated the ultrasound showed the vascular occlusion was not fully resolved.The hcp injected the upper lip with 2 additional vials of hylenex.The hcp continued the vascular occlusion protocol of heat and vigorous massage for the next few hours until the tissue returned to normal.The patient underwent two hyperbaric oxygen treatments following which the hcp reported a full resolution of the vascular occlusion with tissue fully perfused, pink and capillary refill returned to normal.The blister is scabbing and healing.
Additional Manufacturer Narrative
The filler was injected into the patient and is not available for return.The batch release form was reviewed and the device met all specifications prior to release.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.(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: 24967511
• Report Number: 3015260155-2026-00009
• Device Sequence Number: 10496225
• Product Code: LMH
• UDI-Device Identifier: 03760172161271
• UDI-Public: (01)03760172161271(17)270630(10)S2252450013
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/23/2026
• Report Date (Section F): 04/23/2026

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: S2252450013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/14/2026
• Event Location: Other
• Date Report to Manufacturer: 04/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2026
• 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 Sex: Female
• Date Report Sent to FDA: 04/23/2026