MAUDE Adverse Event Report: Symatese Evolysse Form; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	EVO-FRM-01
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Pain (1994); Subcutaneous Nodule (4548); Swelling/ Edema (4577)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient was injected with 0.7 ml of evolysse form in the lips via the provided 30-gauge needle during an onsite training session at her place of employment.An additional 0.1 ml was injected into the cheek.The hcp noted the patient's lips looked "beautiful" but swelled more than previous lip procedures.Before the two-week follow-up, the patient reported palpable lumps in the lips.The provider advised allowing time for the filler to integrate and planned reassessment at two weeks.The patient subsequently reported that the lips felt heavy and using a straw was painful.The hcp examined the patient and could not palpate any lumps or bumps in the lips.However, the filler was dissolved at the patient's request using five vials of hylenex.The provider reported palpating deep nodules that were not visible in the wet mucosa.Over the next four months, the provider dissolved the filler on multiple dates using a total of 21 vials of hylenex.The patient and provider reported improvement; however, residual nodules remain.No adverse reaction was noted in the cheeks.
Additional Manufacturer Narrative
The filler 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.There were three (3) similar complaints of lumps for this lot of product; which is aligned with the risk management file.This is a known side effect listed in the ifu.Injection of evolysse¿ form too superficially and injection in facial areas with limited soft tissue support or soft tissue cover, or thin skin, may result in skin contour irregularities and palpable lumps.Additionally, the product was used off-label in the lip region.We cannot rule out that this may have contributed to the reported event.(b)(4) and (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: geraldine bourges ; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• MDR Report Key: 50288692
• Report Number: 3003672980-2026-00011
• Device Sequence Number: 18814502
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• UDI-Public: (01)03760172161264(17)270228(10)S225107017802
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P240022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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: S2251070178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• 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