MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE LIPS+ (WITH LIDOCAINE); Implant, dermal, for aesthetic use

Model Number	PN40149
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nodule (4551)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prollenium medical technologies (manufacturer) has tried reaching out to the initial reporter for further information however the clinic has not been repsonsive.No further details were shared to allow manufacturer to conduct an internal investigation.The manufacturer is filing an initial report and will continue following up with the clinic and file a follow up report once more details related to the events are available.
Event or Problem Description
Injector had a patient treated at another medspa.Created a nodule on patients skin and when biopsied it came back as silicone.Firm nodules upper and lower mouth treated with hyaluronidase 5 times no resolution so he biopsied and saw silicone.It has lot number and expiration date as 24k198 expires 2026-11-14 (november 14).Clinic has shared no further information to conduct an internal investigation.Internal complaint number: (b)(4).

• Brand Name: REVANESSE LIPS+ (WITH LIDOCAINE)
• Common Device Name: Implant, dermal, for aesthetic use
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n; aurora, ontario L4G4C 3; CA L4G4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n; aurora, ontario L4G 4 C3; CA L4G 4C3
• MDR Report Key: 23854612
• Report Number: 3004423487-2025-00023
• Device Sequence Number: 5128630
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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 Model Number: PN40149
• Device Lot Number: 24K198
• 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: 11/21/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• 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