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

Catalog Number	EVO-SMTH-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erythema (1840); Pain (1994); Local Reaction (2035); Swelling/ Edema (4577)
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.This is a known potential adverse event addressed in the product labeling and risk management file.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.
Event or Problem Description
The healthcare professional reported injecting evolysse smooth subdermally into the cheeks of a patient on (b)(6) 2025.The patient experienced a hard, raised, and reddened area on the left cheek.On (b)(6) 2025, the patient experienced a decrease in the swelling but the area became tender to the touch.Then on (b)(6) 2025, the patient was diagnosed with cellulitis and prescribed keflex.
Event or Problem Description
The healthcare professional injected evolysse smooth subdermally into a female patient's cheeks on (b)(6) 2025.By (b)(6) 2025, the patient developed a swollen, pink, and tender area on her left cheek.She consulted a different dermatologist and was diagnosed with cellulitis, for which she received a seven-day course of keflex.After completing the medication on (b)(6) 2026, the affected area felt firm.On (b)(6) 2026, the area was treated with a 0.5ml injection of hylenex; at the patient's request, another 1ml was injected the following day.By (b)(6) 2026, the firmness had moved lower on her left cheek, prompting another 1ml injection of hylenex.An inconclusive ct scan was reported on (b)(6) 2026.The primary care physician advised discontinuing product dissolution and prescribed another round of keflex.Updated photos sent by the provider after the second keflex course showed that the swelling and redness had resolved as of (b)(6) 2026.
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 product.This is a known potential adverse event addressed in the product labeling and risk management file.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.Follow up 1: b5: added more details of the chronological description of events with specific dates, treatment with hylenex, and patient's current status b6: added date of ct scan performed f10: replaced code 4614 serious injury/illness/impairment with 4619: temporary impairment; as the patient has had a resolution of symptoms h11: added note that the product was used off label.

• 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: 24191575
• Report Number: 3003672980-2026-00001
• Device Sequence Number: 9549905
• Product Code: LMH
• UDI-Device Identifier: 03760172161301
• UDI-Public: (01)03760172161301(17)270717(10)S2252470043
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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-SMTH-01
• Device Lot Number: S2252470043
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2025
• 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: EVOLYSSE FORM INJECTED INTO JAWLINE; EVOLYSSE FORM INJECTED INTO JAWLINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female