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

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	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
They did a half syringe of juvederm volbella on lips on (b)(6) 2024.Also had done a half syringe of volbella prior to that in (b)(6) 2023.No concerns or migration with either of those syringes.Then on (b)(6) they did 1 ml of lips.On the way home the patient texted about "swelling" above the lip.She came back 2 weeks later and the migration was still present.1 cc of hylenex was dissolved and it instantly started changing.3 days later she came back and they did another 1 cc of hylenex along the border.".

• Brand Name: REVANESSE LIPS+ 1.2 ML
• Common Device Name: REVANESSE LIPS+ 1.2 ML
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC; 138 industrial parkway n; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): 138 INDUSTRIAL PARKWAY N; 138 industrial parkway n; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway n; aurora, ontario L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 22761041
• Report Number: 3004423487-2025-00019
• Device Sequence Number: 20871206
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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: 10/04/2026
• Device Model Number: PN40149
• Device Lot Number: 24J105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• 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 Sex: Female
• Patient Race: White