MAUDE Adverse Event Report: ROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE LIPS+ 1.2 ML

Model Number	PN40149
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Easy Bruising (4558)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was verified and has been confirmed to be released by prolleinum.The batch record, qc test reports and qc final inspection review checklist were analyzed and it has been determined that the product was released within final release specifications.
Event or Problem Description
As reported by the injector, 0.5 ml of revanesse lips+ was injected into the lips of a 22-year-old female patient on (b)(6)2025.The patient developed an immediate bruise following the lip injection.The patient took aspirin 48 hour ago, and the bruising did not extend to her face.Prollenium has requested more information from the clinic associated with the injection (e.G.Injection plan,) and patient (medical history) and image before the injection.No further information has been provided despite of several requests by prollenium through email [03-feb-2025, 28-jan-2025, 27-jan-2025,23-jan-2025,20-jan-2025,20-jan-2025,16-jan-2025,14-jan-2025,13-jan-2025,09-jan-2025].The lot number 24k167 was verified and has been confirmed to be released by the company.The batch record, qc test reports, and qc final inspection review check list were analyzed and it has been determined that the product was released within final release specifications.The retrospective review of the batch file shows that no element could explain these issues.The limited information provided by the clinic has been submitted to the prollenium's medical director for review.The medical director's opinion about the reported ae is as follows: "the following is a clinical opinion based on the limited information provided in case (b)(4).On (b)(6) 2025 a patient received 0.5 cc of revanesse lips+ using a needle.During the procedure the patient developed a small bruise on their upper lip.There were no other concerns or adverse event or symptoms.No intervention or treatment was required.The bruise resolved in a few days.My clinical opinion is that this patient received a small bruise from the needle used for injection, which completely resolved.This potential event is outlined in the ifu and clinic consent form." internal ae number: (b)(4).

• Brand Name: REVANESSE LIPS+ 1.2 ML
• Common Device Name: REVANESSE LIPS+
• Manufacturer (Section D): ROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n.; aurora,, on L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): 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: 21339216
• Report Number: 3004423487-2025-00002
• Device Sequence Number: 15590953
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• PMA/510(K) Number: P160042 S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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: 11/16/2025
• Device Model Number: PN40149
• Device Lot Number: 24K167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Race: White