MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES, AURORA, ON REVANESSE LIPS+ 1.2 ML

Model Number	PN40149
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following is a clinical opinion based on the information provided in case (b)(4).On january 22, 2024 a patient received revanesse lips + into their lips, nasolabial folds and lateral perioral smile lines (over the modiolus).A dental block of 2% lidocaine with epi.Was performed pre procedure.There were no concerns or adverse events at the time of injection.On january 26, 2024 the patient called concerned with "swelling" around the right perioral smile line injection.There was no erythema, no inflammation, no pain, no discolouration and no lumps or nodules.There were no other swollen areas.The photos provided shows an isolated fullness in the area of the right perioral injection site.My clinical opinion is that this case represents an area of product that was injected in a suboptimal plane over the modiolus, which is the intersection of multiple muscles that control this highly expressive area of the face.This mobility causes an impression of fullness due to the muscle activity.This appearance will improve with time as the product integrates into the tissue.If waiting is not an option the product can be dissolved with hyluronidase.I trust this clinical opinion will be of value to all parties concerned.".

• Brand Name: REVANESSE LIPS+ 1.2 ML
• Common Device Name: REVANESSE LIPS+ 1.2 ML
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES, AURORA, ON; prollenium medical technologie; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n; aurora, on 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: 18848582
• Report Number: 3004423487-2024-00003
• Device Sequence Number: 20697352
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• PMA/510(K) Number: P160042 S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 03/06/2024

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: 06/27/2025
• Device Model Number: PN40149
• Device Lot Number: 23G034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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: 35 YR
• Patient Sex: Female
• Patient Race: White