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

Model Number	PN40149
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Swelling/ Edema (4577); Dry Skin (4839)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Adverse event information: the injector reports to that the patient was injected with revanesse lips+ (with lidocaine) 1.2ml,23k091 on (b)(6) 2024 on the lips, 1.0ml of product was injected.The patient came for a follow up two weeks later and complained of her lips feeling chapped at the wet dry border.They are tender and irritated and still slightly swollen.The patient has only used aquaphor on her lips for the past few weeks.The patient has had filler previously, but it's been about 1 year ago.Prollenium medical technologies inc.Was not able to consult its medical director owing to the lack of information provided.
Event or Problem Description
Adverse event information: the injector reports to that the patient was injected with revanesse lips+ (with lidocaine) 1.2ml,23k091 on (b)(6) 2024 on the lips, 1.0ml of product was injected.The patient came for a follow up two weeks later and complained of her lips feeling chapped at the wet dry border.They are tender and irritated and still slightly swollen.The patient has only used aquaphor on her lips for the past few weeks.The patient has had filler previously, but it's been about 1 year ago.Prollenium medical technologies' medical director's response to this adverse event can be found below: the following is a clinical opinion based on the limited information provided in case (b)(4).On (b)(6) 2024 a rn injected 1.0cc of revanesse lips + into a patient's lips.The were no concerns or adverse events reported at the time of injection.No past medical history such as medications, allergies or recent infections was provided.No before or after photos were provided.Two weeks later the patient called the injecting rn to complain that her lips " felt dry and chapped".The patient had been applying aquaphor ointment to her lips for 2 weeks.No medical exam was performed or provided by the clinic.The patient provided two selfies of her lip everted and stretched.The photos showed a few normal fordyces glands, no rash, no nodules, and no inflammation.The lips did appear robustly filled which is an injecting technique that creates an unnatural anatomic appearance.My clinical opinion is that there is no evidence presented to support an adverse event in this case.It is important to note that aquaphor ointment contains multiple oils and ingredients that can cause contact or allergic reactions.Lanolin alcohol is well documented to cause skin reactions.Ricinus seed oil (which is processed to make castor oil and the poison ricin) can cause skin reactions.Also, camomile oil is from the compositae family of plants which is closely related to ragweed & chrysanthemums.Any of these ingredients in aquaphor can cause " dry & chapped lips".

• 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
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway north,; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 19795326
• Report Number: 3004423487-2024-00013
• Device Sequence Number: 14489537
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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: User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: 11/03/2025
• Device Model Number: PN40149
• Device Lot Number: 23K091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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