MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA+ 1.2 ML

Model Number	40083
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient received the injection on (b)(6) 2024.Superficial migration of filler observed 6+ months post treatment within wet to dry border on upper lip.Internal report number: (b)(4).
Additional Manufacturer Narrative
Medical opinion from prollenium medical technologies inc.: on (b)(6) 2024 a rn injector injected 1.2 cc of revanesse versa + into a patients lips.There were no concerns or adverse events at the time of injection.No treatment plan was provided however based on the post photo it appears the technique of vertical linear strut was used.Compounded topical anesthetic with lidocaine 23%, tetracaine 7% in "plasticized topical gel", was applied prior to injection."stratamed advanced film-forming wound dressing" was applied to the lips post treatment.No before photos or immediate after photos were provided or taken of area in question.Six or more+ months later the patient noticed a small central area of fullness in the inner central everted lip.There was no pain, no nodules and no signs of inflammation.My clinical opinion is that this case represents suboptimal product placement.This is very common with vertical struts as these are performed very superficially to avoid the superior labial artery and are done without direct visualization.I see no evidence in this case of a product adverse event.

• Brand Name: REVANESSE VERSA+ 1.2 ML
• Common Device Name: REVANESSE VERSA+
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway n,; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 21201900
• Report Number: 3004423487-2024-00032
• Device Sequence Number: 8599329
• 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): 01/17/2025

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: 04/18/2025
• Device Model Number: 40083
• Device Lot Number: 23D117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White