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

Model Number	PN40083
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient received revanesse versa + (w/ lidocaine) (lot 241123) in the nasolabial folds and oral commissures via microcannula on (b)(6) 2025.Was fine up until early (b)(6) 2025; she noticed sudden onset of palpable nodule development on the areas treated.The nodules are palpable, non-tender, and non-erythematous.Patient was offered to resolve product but wanted to hold off since she does like the results not just the palpable nodules.

• Brand Name: REVANESSE VERSA+ (WITH LIDOCAINE)
• 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: colin hall ; 138 industrial parkway n,; aurora, ontario L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 23533999
• Report Number: 3004423487-2025-00022
• Device Sequence Number: 21103153
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): Y
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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: 09/03/2026
• Device Model Number: PN40083
• Device Lot Number: 24I123
• 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: 10/23/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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: 63 YR
• Patient Sex: Female
• Patient Race: White