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

Model Number	40083
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 a patient received 0.25 cc of revanesse versa+ under each eye, in the mid pupillary line.The product was placed on the "orbital rim".Blt compounded topical anesthetic was applied to the area prior to injection.There were no concerns or adverse events at the time of injection.At some unspecified later date the patient complained of swelling under the eyes.There were no nodules, erythema or inflammation.No photos were provided.The product and area was treated with hylenex and rf micro needling.My clinical opinion based on the limited information provided, is that this case represents suboptimal product selection and placement.There is no history of product aes.The patient's dissatisfaction was treated by dissolving the product.Internal report number: (b)(4).

• 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 Contact: ario khoshbin ; 138 industrial parkway n,; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 20636893
• Report Number: 3004423487-2024-00024
• Device Sequence Number: 12639172
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160042 S004
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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: 05/14/2026
• Device Model Number: 40083
• Device Lot Number: 24E144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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
• Patient Age: 45 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: White