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	Pain (1994); Blurred Vision (2137); Neuralgia (4413); Subcutaneous Nodule (4548)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An hcp injected evolysse (type unspecified) into the chin, lips, and midface of a female patient on (b)(6) 2026 during a training event.A few days post injection on (b)(6) 2026, the patient experienced pain, lumps, and blurry vision.The patient was seen by another hcp who injected the patient with 8 vials of hylenex in the cheek area to dissolve as much of the product as possible.As of 22-jul-2026, the patient's vision improved.
Additional Manufacturer Narrative
The filler was injected into the patient and is not available for return.The batch record could not be reviewed as the lot number was not reported.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.(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: 50255051
• Report Number: 3015260155-2026-00012
• Device Sequence Number: 10119054
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• UDI-Public: (01)03760172161264(17)270430(10)S2251630136
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026
• Report Date (Section F): 08/17/2026

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: S2251630136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/17/2026
• Event Location: Other
• Date Report to Manufacturer: 08/17/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 08/17/2026
• 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 Sex: Female
• Date Report Sent to FDA: 08/17/2026