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

Catalog Number	EVO-SMTH-01
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
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.This is a known potential adverse event addressed in the product labeling and risk management file.Injection site reactions, occur the day of or days following the treatment, are localized to the area of injection and may include the following symptoms: lumps, bumps, tenderness/pain, swelling, induration, erythema, bruising.Most injection site reactions will typically resolve within 2 weeks to 30 days.The product was used off-label in the lip region.We cannot rule out that this may have contributed to the reported event.Complaints: (b)(4).Capa-25002.
Event or Problem Description
The healthcare provider reported injecting 0.2cc of evolysse smooth into both sides of the upper lip using the manufacturer provided needle.Immediately following the procedure on (b)(6) 2025, the patient experienced asymmetrical upper lip edema without pain.The capillary refill was normal.

• Brand Name: EVOLYSSE SMOOTH
• 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: 23620937
• Report Number: 3003672980-2025-00158
• Device Sequence Number: 21090516
• Product Code: LMH
• UDI-Device Identifier: 03760172161271
• UDI-Public: (01)03760172161271(17)270131(10)S2250760084
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 11/21/2025

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-SMTH-01
• Device Lot Number: S2250760084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• 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 Age: 23 YR
• Patient Sex: Female