MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA + (WITH LIDOCAINE) 1.2 ML

Model Number	40083
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient came in requesting lip filler.Injector advised she dissolve, but patient requested just enough to add hydration.Injector used.2cc on revanesse lips+ on top right pillow on lower right pillow and added.1cc to piriform fossa on each side.Patient called last night saying she has had burning sensation since injection (one month prior ie.(b)(6) 2025).She did not report because she thought it would improve, but her lips still burn, and she has some pain when applying chapstick.Patient feels she is seeing some whiteness, but provider believes before and after color is consistent based on photos (not provided by the clinic).Event reported on 28-mar-2025.Internal report number: ccr-c-2512.

• Brand Name: REVANESSE VERSA + (WITH LIDOCAINE) 1.2 ML
• Common Device Name: REVANESSE VERSA +
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; CA
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway n; aurora, ontario L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 21921911
• Report Number: 3004423487-2025-00010
• Device Sequence Number: 8719797
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): Y
• PMA/510(K) Number: P160042 S004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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
• Device Expiration Date: 02/20/2026
• Device Model Number: 40083
• Device Lot Number: 24B034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 46 YR
• Patient Sex: Female