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

Model Number	PN40149
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Ecchymosis (1818); Pain (1994); Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Event or Problem Description
Based on the information received from the clinic, a 49-year-old female patient underwent facial filler treatment with revanesse lips+ 1.2 ml, lot number 24d112, on (b)(6) 2026.The patient was injected 2 syringes of revanesse lips+ in the marionette lines, smile lines and cheeks.The clinic's injector reports that right marionette was injected superficially with needle and with a 22g 2" dermsculpt cannula.A tiny bruise popped up right away on the right side with the last superficial injection.The clinic reports that next day (b)(6) 2026, the bruise went from a pencil eraser size to a half deep purple and slight dusky area that had very slow capillary refill and pain 5/10.Additional clarification received from the clinic (injector) on 24 apr 2024: the actual chin was not injected; treatment in this region was limited to the bilateral pre-jowl sulcus areas.The injector reported to manufacturer that, she initiated a treatment protocol.Firstly with 1 vial of hylenex going in superficially and flooding the area, followed by massage and heat application.The patient still reported a pain score of 3/10 but with still sluggish capillary refill.20 minutes had elapsed and 1 additional vial was injected to the area superficially and deep.Massaged and capillary refill was then back to being quick and pain still remained a 3/10.Heat applied and then re-evaluated 20 minutes later.The injector reported that she injected 1 additional vial to ensure the area was covered and when the patient left a total of 3 vials of hylenex had been injected and normal capillary refill returned and decreased pain.Along with the area going from a deep purple to a lighter color and no dusky area.Continued follow up to ensure the are was continuing to improve.The patient will be following up with the injector on the (b)(6) 2026 for evaluation and retreatment of the area.As part of the investigations, prollenium's medical technologies inc.Had requested its own medical director's opinion and her review is detailed below: medical assessment by manufactur's medical director assessment: the reported event is most consistent with suspected early vascular compromise recognized promptly and managed appropriately with timely intervention, with apparent favorable resolution and no reported tissue loss.Features supporting this assessment include: immediate evolution of dusky discoloration, delayed capillary refill, associated pain, improvement following high-dose hyaluronidase administration with return of normal capillary refill.The clinical course and response are consistent with a procedure-related vascular event, likely related to injection technique and vascular interaction, rather than evidence of a product-related defect.Category: h.Vascular procedure-related vascular adverse event (resolved without sequelae reported).Causality assessment: device-related defect [?]: unlikely.Procedure-related vascular event [?]: likely.Other contributing factors (patient-specific anatomy / injection-related factors) [?]: possible.Overall classification: adverse event consistent with suspected vascular compromise, procedure-related in origin.Corrective action: no corrective action related to product quality or manufacturing is indicated based on the available information.

• Brand Name: REVANESSE LIPS+ WITH LIDOCAINE 1.2 ML
• Common Device Name: REVANESSE LIPS+ WITH LIDOCAINE
• 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 L4G4C 3; CA L4G4C3
• Manufacturer Contact: david alphonso ; 138 industrial parkway north,; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 25087267
• Report Number: 3004423487-2026-00003
• Device Sequence Number: 21440996
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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 Expiration Date: 04/03/2026
• Device Model Number: PN40149
• Device Lot Number: 24D112
• 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: 04/06/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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 Age: 49 YR
• Patient Sex: Female