MAUDE Adverse Event Report: Prollenium Medical Technologies Inc. Revanesse Lips+ (with Lidocaine); 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	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury

• 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 L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): Prollenium Medical Technologies Inc.; 138 industrial parkway n,; aurora, ontario L4G4C 3; CA L4G4C3
• Manufacturer Contact: david alphonso ; 138 industrial parkway n,; aurora, ontario L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 50142396
• Report Number: 3004423487-2026-00006
• Device Sequence Number: 9349549
• 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: Consumer
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

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: 07/28/2026
• Device Model Number: PN40149
• Device Lot Number: 26B100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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: 63 YR
• Patient Sex: Female