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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMATESE EVOLYSSE FORM; IMPLANT, DERMAL, FOR AESTHETIC USE
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SYMATESE EVOLYSSE FORM; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number EVO-FRM-01
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Swelling/ Edema (4577)
Date of Event 07/18/2025
Type of Reportable Event Serious Injury
Event or Problem Description
The heatlh care professional reported injecting a patient with 2cc of evolysse form into one side of the patient's midface and nasolabial folds.Approximately one (1) month post injection, the patient experienced swelling.The patient was treated with two (2) rounds of hyaluronidase.
 
Additional Manufacturer Narrative
Complaint number: (b)(4).
 
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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 Key23351085
Report Number3015260155-2025-00110
Device Sequence Number15655258
Product Code LMH
UDI-Device Identifier03760172161271
UDI-Public(01)03760172161271(17)270228(10)S2250920009
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/21/2025
Report Date (Section F) 09/29/2025
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 NumberEVO-FRM-01
Device Lot NumberS2250920009
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/25/2025
Event Location Other
Date Report to Manufacturer09/29/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/21/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexFemale
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