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

Model Number	PN40149
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The batch record, qc test reports, and qc final inspection review check list were analyzed and it has been determined that the product was released within final release specifications.The retrospective review of the batch file shows that no element could explain these issues.The lot number 25e162 was verified and has been confirmed to be released by the company.
Event or Problem Description
On tuesday, (b)(6) 2025, a female patient contacted prollenium customer service to report an adverse event.She stated that she had been treated with revanesse lips and experienced an allergic-type reaction, including tingling and a sensation of heat/burning on her face.The prollenium medical affairs team contacted the clinic and requested additional information, which was subsequently provided.According to the clinic, on (b)(6) 2025, the patient was injected with revanesse lips+ as follows: 0.5 ml injected into the lips 0.5 ml** injected around the mouth.For patient comfort, topical lidocaine numbing cream was applied to the lips and perioral area.Prior to lidocaine application, the area was prepped using hibiclens and an alcohol pad.As the patient's request, acne scars around the mouth were also treated.For this purpose: 0.2 ml of filler was hyper-diluted with 0.9% sodium chloride at a 1:1 ratio.The product was injected superficially using a 31-gauge needle provided in the package.Additional comfort measures included topical lidocaine cream and intermittent ice pack application.The area was further prepped with hibiclens and an acetone/ethanol solution to allow for adequate numbing.All injections were performed using the provided syringe and needle, with aspiration performed prior to each injection.The patient tolerated the procedure well.Post-treatment care instructions were reviewed, and a follow-up visit was recommended in two weeks if needed, or sooner if concerns arose.The patient verbalized understanding and was encouraged to contact the clinic with any questions or concerns.Ibuprofen (anti-inflammatory) was administered.The patient has an extensive medical history, including: history of unspecified autoimmune condition breast cancer diagnosed in 2005, treated with surgery and radiation breast reconstruction with implants in 2009 removal of breast implants in 2021 following pfizer covid-19 vaccination due to concern for possible breast implant illness (bii).The patient has known allergies to aspirin, penicillin, strawberries, and pineapple.She previously received juvederm and restylane treatments without any adverse reactions.Following symptom onset, the patient was advised to take an antihistamine, but she chose not to do so.She later sought care at an urgent care facility, where a steroid was prescribed; however, she did not take the medication due to upcoming travel.The batch record, qc test reports, and qc final inspection review check list were analyzed and it has been determined that the product was released within final release specifications.The retrospective review of the batch file shows that no element could explain these issues.The lot number 25e162 was verified and has been confirmed to be released by the company.The information provided by the clinic has been submitted to the prollenium's medical director for review.The medical director's opinion about the reported ae is as follows: "the following is a clinical opinion based on the information provided in (b)(4).On (b)(6) 2025 a patient received 1.0 cc of revanesse lips+ into and around her lips.There were no concerns or adverse events at the time of injection.The area was cleaned with hibiclens, acetone & alcohol and received an application of topical lidocaine (no concentration provided) prior to injection.The patient has a very extensive past medical history including food and asa allergies, sensitivity to led lights, bilateral cataracts, breast and thyroid cancers (treatment for both involved surgery and radiation) and an " unspecified" autoimmune condition.The patient did not contact the clinic with any post procedure concerns.On (b)(6) 2025 the patient called prollenium customer services complaining of "tingling and hotness" around her eyes.The photos provide show no erythema, rash, nodules or inflammation in or around the lips, where filler was deposited.The eyes (where the symptoms were described) were blacked out.There were no signs or evidence of an adverse event to ha filler.My clinical opinion is that this case does not represent a product adverse event.The peri-occular symptoms may be related to one of the patients other medical conditions." internal complaint number: (b)(4).

• Brand Name: REVANESSE LIPS+
• Common Device Name: REVANESSE LIPS+
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n.; aurora,, on L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n.; aurora, ontario L4G4C 3; CA L4G4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway n.; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 23881660
• Report Number: 3004423487-2025-00024
• Device Sequence Number: 4669243
• 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 Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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 Model Number: PN40149
• Device Lot Number: 25E162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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
• Patient Race: White