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	Bacterial Infection (1735); Pain (1994); Subcutaneous Nodule (4548); Swelling/ Edema (4577)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
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 no similar complaints for this lot of products.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 or inadequate post-care, often contribute to this issue.Treatment with antibiotics usually resolves symptoms fully without lasting effects.The product was used off-label in the cheek region.We cannot rule out that this may have contributed to the reported event.(b)(4).
Event or Problem Description
An hcp reported injecting 2cc's of evolysse form bilaterally into the midface and cheeks of a female patient on (b)(6) 2026.One (1) day following the injection on (b)(6) 2026, the patient returned to the office experiencing pain and swelling of the right cheek.The hcp prescribed oral antibiotics of doxycycline and keflex.On (b)(6) 2026, the hcp drained the right cheek and collected a culture which came back positive for a staphylococcal infection.The same day the hcp administered an injection of kenalog.On (b)(6) 2026 the hcp administered a second kenalog injection.A small nodule remained which was injected with hylenex on (b)(6) 2026.Then the patient was re-injected with evolysse form on (b)(6) 2026.Procedure preparation: the hcp cleaned the injection area with alcohol, hibiclens, and puracyn.

• 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: 25444417
• Report Number: 3003672980-2026-00010
• Device Sequence Number: 5815381
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• UDI-Public: (01)03760172161264(17)270331(10)S2251330076
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: S2251330076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALCOHOL.; HIBICLENS.; PURACYN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female