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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 Subcutaneous Nodule (4548)
Date of Event 09/09/2025
Type of Reportable Event Serious Injury
Event or Problem Description
The healthcare professional reported injecting evolysse form into the lips of a patient.Patient had extreme swelling initially.Then approximately ten (10) days post injection, patient had hard masses/nodules in lips.The hcp dissolved the product with two (2) vials of hylenex and antibiotics.Patient had a complete resolution of symptoms.
 
Additional Manufacturer Narrative
Eus (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 Key23430154
Report Number3015260155-2025-00113
Device Sequence Number9854395
Product Code LMH
UDI-Device Identifier03760172161264
UDI-Public(01)03760172161264(17)20270228(10)S2250900178
Combination Product (Y/N)N
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) 10/30/2025
Report Date (Section F) 10/15/2025
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 NumberS2250900178
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/01/2025
Event Location Other
Date Report to Manufacturer10/15/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/30/2025
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 SexUnknown
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