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

Catalog Number	EVO-FRM-01
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Skin Discoloration (2074); Twitching (2172); Obstruction/Occlusion (2422)
Date of Event	12/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 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.
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.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 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.(b)(4).

• 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
• Manufacturer (Section G): SYMATESE; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• Manufacturer Contact: laurence hermitte ; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• MDR Report Key: 24248675
• Report Number: 3003672980-2026-00002
• Device Sequence Number: 13166351
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• UDI-Public: (01)03760172161264(17)270531(10)S2251850090
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P240022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• 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