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); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Anaphylactoid / Anaphylaxis (2218); Pallor (2468)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury

• 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: 50950438
• Report Number: 3015260155-2026-00017
• Device Sequence Number: 10429279
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/30/2026
• Report Date (Section F): 09/30/2026

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: S2252880126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/03/2026
• Event Location: Other
• Date Report to Manufacturer: 09/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2026
• 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: 50 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/30/2026