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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Local Reaction (2035); Skin Infection (4544)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the healthcare provider (hcp) injected 1ml of evolysse form into a patient's lips.On (b)(6) 2026, the patient noticed some filler oozing from her bottom lip, though she denied manipulating the area herself.The hcp recommended she apply ice to the site intermittently.As of (b)(6) 2026, the patient was out of the country and unable to attend an office visit.On (b)(6) 2026, the hcp contacted the patient again to arrange a follow-up.The patient reported that prior to leaving the country, the filler had oozed from her bottom lip, causing a burning sensation and swelling.While abroad, she was prescribed a five-day course of antibiotics due to concerns about a localized infection.Currently, the patient has a hardened lump on one side of her bottom lip.The reporting hcp has not yet evaluated the patient in person.
Additional Manufacturer Narrative
The filler was injected into the patient and is not available for return.The batch release form was reviewed and the device met all specifications prior to release.This is a known potential adverse event addressed in the product labeling.As with all transcutaneous procedures, soft tissue filler implantation carries a risk of infection.This is typically caused by various bacteria entering through a disrupted skin barrier.Additionally, poor aseptic technique, inadequate post-care, or intraoral injections often contribute to this issue.Treatment with antibiotics usually resolves symptoms fully without lasting effects.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).

• 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: 24563441
• Report Number: 3015260155-2026-00005
• Device Sequence Number: 18540210
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• UDI-Public: (01)03760172161264(17)270531(10)S2251990226
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/10/2026
• Report Date (Section F): 03/10/2026

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: S2251990226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2026
• Event Location: Other
• Date Report to Manufacturer: 03/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2026
• 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: 03/10/2026