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

Catalog Number	EVO-SMTH-01
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Swelling/ Edema (4577)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a healthcare professional injected 1cc of evolysse smooth into a patient's lips.On (b)(6) 2025, the patient received injections of tirzepatide and vitamin b3, after which they experienced swelling at the injection site, as well as lip swelling and tingling.That same day, the healthcare provider referred the patient to the emergency room (er), where treatment included intravenous epinephrine and steroids, followed by a 10-day course of oral steroids.On (b)(6) 2025, the final day of oral steroids, the patient again had swollen lips.The patient visited their primary care provider (pcp) on (b)(6) 2025, was prescribed oral steroids, and referred to an allergist.The patient's lip swelling subsided once oral steroids were re-started.
Additional Manufacturer Narrative
The filler was injected into the patient and is not available for return.Inflammatory responses, such as swelling or erythema, can develop near sites of dermal filler injection following viral or bacterial illnesses, vaccinations, or dental interventions.In certain instances, adverse effects may present weeks, months, or even years after the procedure; this is a recognized potential adverse event as stated in the product labeling.In this case, the product was administered off-label to the lip region.The reaction occurred soon after the administration of tirzepatide and vitamin b3.Consequently, we cannnot rule out that this may be possible causation of the reaction.Complaints: (b)(4).

• 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: 23789359
• Report Number: 3003672980-2025-00171
• Device Sequence Number: 18759556
• Product Code: LMH
• UDI-Device Identifier: 03760172161271
• UDI-Public: (01)03760172161271(17)270331(10)S2251530008
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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): 12/12/2025

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-SMTH-01
• Device Lot Number: S2251530008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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: TIRZEPATIDE; VITAMIN B3 INJECTION
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female