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

Catalog Number	EVO-FRM-01
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Blister (4537); Skin Infection (4544); Subcutaneous Nodule (4548)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The heatlhcare professional (hcp) reported administering a dental block with lidocaine, cleansing the lips with purycin topical cleanser, and then injecting less than one syringe of evolysse smooth into the lips of the patient on (b)(6) 2025.On (b)(6) 2025, the patient experienced blisters on the lower lip following contact with a family member that also had lip blisters, upon return from puerto rico.The patient tested positive for impetigo and was treated with antibiotics by primary care physician.On (b)(6), 2025, the patient experienced a firm lump to the left side of her upper lip.No pain, redness, or discoloration was observed.The patient self medicated with claritin; no improvement in symptoms.A separate hcp prescribed a medrol pack, zyrtec, and famotidine; patient started this treatment regimen on (b)(6) 2025.The patient experienced a full resolution of symptoms until completion of the treatment regimen, then the symptoms returned.On (b)(6) 2025; the product was dissolved with 1 vial of hylenex to the upper and lower lips following administration of a lidocaine numbing block; a subsequent treatment with hylenex was performed on (b)(6) 2025.The symptoms persist.
Additional Manufacturer Narrative
The filler was injected into the patient and is not available for return.A review of the device history record has been initiated.The investigation is on-going; any new, changed or updated information will be included in the corresponding manufacturer's report.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.The patient was exposed to impetigo from a close family member which could be a contributing factor to the outbreak.Additionally, the product was used off-label in the lip region.We cannot rule out that these factors may have contributed to the reported event.Complaints: (b)(4).Updated information manufacturer report.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.

• 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: 23705626
• Report Number: 3003672980-2025-00170
• Device Sequence Number: 13410687
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• UDI-Public: (01)03760172161264(17)270228(10)S2250900177
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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 Practitioner
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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-FRM-01
• Device Lot Number: S2250900177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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: BUPROPION 150MG QD FOR DEPRESSION.; ESCITALOPRAM 10MG QD FOR DEPRESSION.; SPIRONOLACTONE 50MG QD FOR CYSTIC ACNE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female