MAUDE Adverse Event Report: Symatese Evolysse Form; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	EVO-FRM-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Obstruction/Occlusion (2422); Pallor (2468)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An hcp reported injecting 0.2 cc of evolysse form into a patient's pyriform aperture using a 25-gauge cannula.When the tissue blanched, the hcp immediately withdrew the cannula, injected two vials of hylenex, applied a warm compress, and massaged the area.The patient subsequently developed bruising and mottling.An md confirmed a vascular occlusion in the left nasolabial fold, which resolved after ultrasound-guided hylenex treatment.
Additional Manufacturer Narrative
The product was injected into the patient and is not available for return.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.There were no similar complaints received for this lot of product.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 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: geraldine bourges ; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• MDR Report Key: 50803126
• Report Number: 3003672980-2026-00016
• Device Sequence Number: 8596998
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• UDI-Public: (01)03760172161264(17)270531(10)S2252040274
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 09/17/2026

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: S2252040274
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• 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 Age: 56 YR
• Patient Sex: Female