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

Model Number	PN40149
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Adverse event information: the injector reports that patient was injected on (b)(6) 2024 with revanesse lips+ with lidocaine on (b)(6) 2024 in 0.5 ml cupid's bow, red vermillion tubercle, upper and lower lips.The injector reports that she observed on (b)(6) 2024 the patient shows two small improving nodules are present at the corners of the mouth and two on the upper lip, continuing to decrease in size.The nodules at the mouth corners are semi-hard and tender, with no erythema, signs of infection, or biofilm.No fever is present.Mild swelling is noted, consistent with delayed-onset nodules.The patient has completed the second course of prednisone 60 mg taper and a prophylactic course of ciprofloxacin 500 mg.Over the course of 9 visits from (b)(6) 2024 to (b)(6) 2025, the patient underwent treatment that included intralesional hylenex and kenalog-40 injections, oral steroid courses, and ultrasound imaging.Prollenium has reached out to the injector/clinic multiple time to obtain more information to conduct a through investigation however no response was provided.

• Brand Name: REVANESSE LIPS+ (WITH LIDOCAINE) 1.2 ML
• Common Device Name: REVANESSE LIPS+ (WITH LIDOCAINE) 1.2 ML
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway north; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC,; 138 industrial parkway north,; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway north,; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 21911776
• Report Number: 3004423487-2025-00011
• Device Sequence Number: 12579475
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P160042 S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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 Expiration Date: 09/08/2025
• Device Model Number: PN40149
• Device Lot Number: 23I030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female