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.
Event or Problem Description
An hcp reported injecting (b)(6)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.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.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.
Additional Manufacturer Narrative
The product was injected into the patient and is not available for return.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.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.Follow-up 1: 17-sep-2026 the batch release form was reviewed, and the device met all specifications prior to release.D4 additional device information: lot number, udi, and expiration date were added (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
• MDR Report Key: 50692220
• Report Number: 3015260155-2026-00016
• Device Sequence Number: 14925378
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• UDI-Public: (01)03760172161264(17)270531(10)S2252040274
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 09/17/2026
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/21/2026
• Event Location: Other
• Date Report to Manufacturer: 09/17/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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 Age: 56 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/17/2026