MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA+ 1.2 ML

Model Number	PN40083
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Easy Bruising (4558)
Date of Event	03/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the injector, pa-c, a 35-year-old female patient was injected with 0.2 ml of revanesse versa+ into her top right upper lip.The patient had a history of lip sores and took valtrex before the injection.The injector aspirated before each injection & showed good capillary refill after injection.The injector asked if patient was in pain, pt.Said there was pain but not intense.On day 2, the patient experienced intense pain (9/10).The right upper lip's vermilion border developed a hematoma.The patient was referred to dr.Sayeed in plastics, who used two vials of hylenex to flush out a possible vascular occlusion (vo).On day 3, the patient reported blurry vision, and a cta of the head and neck came back normal.By day 4, the patient had bruising extending above the lip, with normal pain and sensation.Bruising persists.The plastic surgeon suspects this may be a case of vascular occlusion in the upper lip.The pt.Got a second opinion by dr.(b)(6) in (b)(6); who diagnosed her with ecchymosis.The information provided by the clinic and the patient 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 case (b)(4).On (b)(6) 2025 a patient received 0.2cc of revanesse versa+ into her right upper lip.There were no concerns or adverse events at the time of injection.The post treatment photo showed no bruises, nodules or vascular compromise.One day later the patient contacted the clinic complaining of "intense pain" and bruising in the injection area.The patient was seen by a plastic surgeon who used 2 vials of hylenex to dissolve any product in the area.There was no record of tissue damage or necrosis.No photos were provided.The surgeon suspected "a possible vascular occlusion" but did not offer a definitive diagnosis.A second physician, who was sought out by the patient as a second opinion, diagnosed the findings and history as a bruise.My clinical opinion, based on the information provided, is that this case represents a treatment hematoma (bruise).The area was appropriately treat as a vascular occlusion, as this is a differential diagnosis that can not be missed." internal ae number: (b)(4).
Additional Manufacturer Narrative
The lot number was verified and has been confirmed to be released by prolleinum.The batch record, qc test reports and qc final inspection review checklist were analyzed and it has been determined that the product was released within final release specifications.

• Brand Name: REVANESSE VERSA+ 1.2 ML
• Common Device Name: REVANESSE VERSA+
• 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, on L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway n.; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 21943791
• Report Number: 3004423487-2025-00012
• Device Sequence Number: 15592066
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160042 S004
• 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
• Initial Reporter Occupation: Physician Assistant
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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: 10/03/2026
• Device Model Number: PN40083
• Device Lot Number: 24J104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Race: White