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

Catalog Number	EVO-FRM-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported injecting a patient with evolysse form in the lips.Approximately two (2) weeks post injection, the patient experienced lumps and bumps in the lips like the product did not settle.The hcp dissolved the product and the symptoms resolved.
Additional Manufacturer Narrative
The filler was injected into the patient and is not available for return.The event is a physiological event complication and analysis of the device does not assist in determining a probable cause of the event.This is a known potential adverse event addressed in the product labeling.However, it was noted that the practitioner did not follow the instructions for use regarding the recommended injection site (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: 23439694
• Report Number: 3003672980-2025-00131
• Device Sequence Number: 4695334
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• UDI-Public: (01)03760172161264(17)2027022810)S2251120199
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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: S2251120199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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: Other
• Patient Sex: Female