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

Model Number	PN40149
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Injection Site Pooling (4840)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient information: the patient is a 40-year-old female with hsv type i with last outbreak 1 year ago, no history of injections or allergies.Also does not have auto immune conditions.Adverse event information: the clinic reported on (b)(6) 2025 that patient who was injected on (b)(6) 2025 with 4 ml of revanesse lips+ with lidocaine showed angioedema 5-10 minutes post starting injection.However, the clinic manager reported to prollenium medical that the patient is doing fine now.Follow-up communications with clinic: after receiving the report on 16 apr 2025 by prollenium, they reached out to the clinic to obtain more information to conduct a through investigation.Results of medical assessment: on (b)(6) 2025 a patient received less than 0.4 cc of revanesse lips into her upper lip.Prior to injection the injecting rn applied compounded high concentration topical anesthetic blt (benzocaine, lidocaine, tetracaine) to the patient's upper and power lips.Within 5 min of injecting the upper lip the patients both lips swelled in an allergic nature.The patient was given one benadryl 50 mg tablet and the swelling subsided.The small amount of ha was not dissolved.The swelling did not reoccur."my clinical opinion is that is a commonly seen allergic reaction caused by high concentration of topical anesthetic applied to the thin epithelium and mucosa of the lips.Benzocaine is the most allergenic of all topical anesthetics.I see no evidence of this being an adverse event caused by ha filler as the filler was not dissolved and the allergic swelling did not return.".
Additional Manufacturer Narrative
Medical opinion from prollenium medical technologies inc.: on (b)(6) 2025 a patient received less than 0.4 cc of revanesse lips into her upper lip.Prior to injection the injecting rn applied compounded high concentration topical anesthetic blt (benzocaine, lidocaine, tetracaine) to the patient's upper and power lips.Within 5 min of injecting the upper lip the patients both lips swelled in an allergic nature.The patient was given one benadryl 50 mg tablet and the swelling subsided.The small amount of ha was not dissolved.The swelling did not reoccur."my clinical opinion is that is a commonly seen allergic reaction caused by high concentration of topical anesthetic applied to the thin epithelium and mucosa of the lips.Benzocaine is the most allergenic of all topical anesthetics.I see no evidence of this being an adverse event caused by ha filler as the filler was not dissolved and the allergic swelling did not return.".

• Brand Name: REVANESSE LIPS+ (WITH LIDOCAINE)
• Common Device Name: REVANESSE LIPS+ (WITH LIDOCAINE)
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC; 138 industrial park way north; aurora, ontario L4G4C 3; CA L4G4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES; 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: 22006372
• Report Number: 3004423487-2025-00009
• Device Sequence Number: 7220661
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Administrator/Supervisor
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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: 02/05/2026
• Device Model Number: PN40149
• Device Lot Number: 24E135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 05/12/2025
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White