MAUDE Adverse Event Report: TEOXANE S.A. TEOSYAL; IMPLANT, DERMAL, FOR AESTHETIC USE

Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Fibrosis (3167); Angioedema (4536)
Date of Event	05/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Teoxane lip filler caused severe angioedema leaving me with lip lumps and fibrotic tissue and still on my first round of hyaluronidase.

• Brand Name: TEOSYAL
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): TEOXANE S.A.
• MDR Report Key: 22729059
• Report Number: MW5174104
• Device Sequence Number: 7496658
• Product Code: LMH
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White