MAUDE Adverse Event Report: Prollenium Medical Technologies Inc. Revanesse Lips+ with Lidocaine Kit 1.2 mL; Implant, Dermal, For Aesthetic Use

Model Number	PN40149
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 38-year-old female received 0.3 ml of revanesse lips+ (lot: 25l069) in the upper lip on (b)(6) 2026.Within approximately 5 minutes of injection, localized swelling of the upper lip was observed, and the injector discontinued treatment.Ice was applied and cold compresses were offered.No other medications were administered.The patient had previously received lip filler treatment at another clinic several months earlier., reportedly rha2.No autoimmune condition was reported.Topical anesthetic sknv 23/7% was used.Photographs obtained on (b)(6) 2026 demonstrated localized upper-lip fullness and mild asymmetry without evidence of tissue necrosis or vascular compromise.The event was assessed as localized swelling/edema following treatment and classified as a non-serious adverse event.

• Brand Name: Revanesse Lips+ with Lidocaine Kit 1.2 mL
• Common Device Name: Implant, Dermal, For Aesthetic Use
• Manufacturer (Section D): Prollenium Medical Technologies Inc.; 138 industrial parkway n,; aurora,, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): Prollenium Medical Technologies Inc.; 138 industrial parkway n,; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: denis vezina ; 138 industrial parkway n,; aurora,, ontario L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 50843103
• Report Number: 3004423487-2026-00007
• Device Sequence Number: 18656965
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• 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: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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 Model Number: PN40149
• Device Lot Number: 25L069
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• 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: 38 YR
• Patient Sex: Female
• Patient Race: White