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

Catalog Number	EVO-FRM-01
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Skin Discoloration (2074); Twitching (2172); Reduced Blood Flow (4598)
Date of Event	12/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the reported information, this event is consistent with a vascular occlusion which is a known serious adverse event documented in the labeling and risk management file.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.Eus-20260105-5[1].
Event or Problem Description
On december 22, 2025 the hcp reported injecting 1cc of evolysse form into the lips and nasolabial folds of a patient.By (b)(6) 2025, the patient experienced discoloration in the upper lip which they described as "dusky" along with eye twitching and pain.Massage temporarily improved the discoloration, but symptoms returned when stopped.On (b)(6) 2026, the hcp suspected a vascular occlusion and administered 10 vials of amphadase, resulting in minimal improvement; massage, heat, and aspirin were prescribed.Another hcp performed an ultrasound of the patient on (b)(6) 2026 and diagnosed the patient with bilateral vascular occlusions in both oral commissures with redness extending from the corner of the mouth to the corner of the eye.The hcp injected 2 vials of hyaluronidase and patient experienced an improvement of symptoms.The patient's symptoms resolved as of (b)(6) 2026.

• Brand Name: EVOLYSSE FORM
• 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: 24054514
• Report Number: 3015260155-2026-00002
• Device Sequence Number: 10023040
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• UDI-Public: (01)03760172161264(17)270531(10)S2251850090
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 01/13/2026
• Report Date (Section F): 01/05/2026

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-FRM-01
• Device Lot Number: S2251850090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/02/2026
• Event Location: Other
• Date Report to Manufacturer: 01/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2026
• 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