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

Model Number	PN40149
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
Based on the information received from the clinic, the patient, female, age not confirmed was injected with revanesse lips,1.2ml (lot number was not confirmed) in the lips and experienced immediate swelling, swelling was observed to be persistent and not reducing down.The clinic also reported that a similar reaction had occurred following a previous treatment, where the same patient experienced lip swelling each morning that resolved gradually throughout the day and persisted for several months.This reaction did not occur when the patient was previously treated with rha redensity.Prollenium has reached out to the clinic multiple time to obtain more information to conduct a through investigation; however no response was provided.Adverse event clinical narrative: a female patient of unspecified age underwent lip augmentation with revanesse lips.The exact treatment date, injection technique, and volume administered were not provided.Immediately following treatment, the patient developed significant lip swelling that did not resolve as expected in the acute post-procedural period.It was further reported that the patient had experienced a similar reaction following a previous dermal filler treatment, characterized by recurrent lip swelling occurring each morning, with gradual resolution throughout the day.This pattern reportedly persisted over several months.The patient did not experience similar reactions when previously treated with rha redensity.No additional clinical details were provided, including presence or absence of erythema, pain, nodularity, induration, systemic symptoms, or signs suggestive of vascular compromise or infection.No photographic documentation or ultrasound imaging was available.No information was provided regarding post-treatment management, including whether hyaluronidase, corticosteroids, antihistamines, or antibiotics were administered.Relevant patient medical history, including autoimmune status, allergy history, medications, and prior filler exposure details, was not provided.A definitive medical assessment cannot be established based on the information currently available.Key elements required for appropriate clinical evaluation and causality assessment are missing, including: pre-and post-treatment clinical photographs detailed characterization of swelling (onset, duration, severity, associated symptoms) information on injection technique, depth, and total volume injected full patient medical history, including allergies, autoimmune conditions, and prior filler tolerance documentation of any treatments administered (e.G., antihistamines, corticosteroids, hyaluronidase) lot number for product traceability and batch evaluation.

• Brand Name: REVANESSE LIPS+ WITH LIDOCAINE 1.2 ML
• Common Device Name: REVANESSE LIPS+ WITH LIDOCAINE 1.2 ML
• 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 L4G 4 C3; CA L4G 4C3
• MDR Report Key: 24771833
• Report Number: 3004423487-2026-00001
• Device Sequence Number: 13336887
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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 Model Number: PN40149
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female