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

Catalog Number	PN40149
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to limited information, prollenium could not complete internal investigation including review the batch record, qc test reports, and qc final inspection review check list.
Event or Problem Description
On thursday, (b)(6) 2026, a female patient contacted answerconnect to report an adverse event.According to the patient, she received injections of revanesse® lips+ in her lips.She reported asymmetry of the lips, noting that the right side appeared fuller than the left side following the treatment.The patient expressed concern regarding this outcome and requested to speak with a contact person from prollenium to obtain assistance in resolving the issue.The patient declined to disclose the name of the clinic or healthcare provider where the injection was administered.No further details were available regarding the product, including lot number, or regarding the patient's demographic or medical background (e.G., age, medical history).Additionally, no information was provided on the injector and treatment plan, including dosage, injection technique, or pre or post treatment care.Following receipt of the report, the prollenium medical affairs team attempted to contact the patient multiple times (b)(6) 2026, using the phone number she provided in order to obtain additional.However, the patient did not answer the phone.Due to the limited information available, prollenium was unable to complete the internal investigation, including a review of the batch records and qc testing records.The limited information received was reviewed by the prollenium medical director, whose clinical opinion is provided below: assessment: based on the limited information available, the reported concern is isolated lip asymmetry following dermal filler injection, without associated inflammatory or vascular features.Lip asymmetry is a recognized post-procedural outcome in aesthetic lip augmentation and may result from uneven product distribution, injection technique variability, or pre-existing anatomical asymmetry.Limitations a definitive medical assessment remains limited due to absence of: treatment details (volume, technique, injection plane) clinical documentation or imaging baseline anatomical assessment follow-up evaluation.Category: non-adverse aesthetic outcome.(post-procedural asymmetry) causality assessment: device-related defect - unlikely procedure-related outcome - likely other contributing factors.(e.G., baseline asymmetry) - possible overall classification: consistent with a non-medical, technique-related aesthetic outcome.Corrective action: no corrective action related to product quality or manufacturing is indicated based on the available information.Clinical follow-up with a qualified injector may be considered to assess symmetry and determine whether minor corrective treatment is appropriate.(b)(4).

• Brand Name: REVANESSE LIPS+
• Common Device Name: REVANESSE LIPS+
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n.; 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, ontariio L4G4C-3 ; CA L4G4C3
• MDR Report Key: 24920939
• Report Number: 3004423487-2026-00002
• Device Sequence Number: 14797739
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 04/18/2026

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 Catalogue Number: PN40149
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/18/2026
• 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