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)
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 0.6cc 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 (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.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.The production records for the lot were reviewed, and no deviations were found during production that would relate to the reported event; the device met all specifications.Eus: (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
• Manufacturer (Section G): SYMATESE; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• Manufacturer Contact: geraldine bourges ; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• MDR Report Key: 25112166
• Report Number: 3003672980-2026-00009
• Device Sequence Number: 21137024
• Product Code: LMH
• UDI-Device Identifier: 03760172161271
• UDI-Public: (01)03760172161271(17)270630(10)S2252450013
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P240022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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: Required Intervention
• Patient Sex: Female