MAUDE Adverse Event Report: BNC GLOBAL TESORO LIP FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE

Health Effect - Clinical Code	Cyanosis (1798)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
I went to get lip filler from a lady in (b)(6) called (b)(6) who claims to be licensed but she injected me with something that turned my nose blue.

• Brand Name: TESORO LIP FILLER
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): BNC GLOBAL; m-2804, songdo technopark it center 32; songdowahak-ro, yeonsu-gu, incheon
• MDR Report Key: 22529638
• Report Number: MW5172818
• Device Sequence Number: 19873160
• Product Code: LMH
• Combination Product (Y/N): N
• 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): 07/13/2025

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: Other
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American