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

Model Number	40083
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 a patient received 1.2 cc of revanaesse versa+ into their lips.There were no concerns or adverse events at the time of injection.At some later unknown date the patient felt there was "swelling and lumps" in their lips.The patient's physician put the patient on prednisone which resolved the symptoms.On (b)(6) 2024 the "swelling and lumps" returned.The patient was seen by the injector who dissolved the "areas of concern" with hylenex and the patients concerns resolved.Due to the lack of medical information in this case, it is difficult to provide an accurate clinical opinion.My view is that this represents a case of suboptimal lip filling that resulted in lumpy distribution of product.This was easily resolved with the injection of hyluronidase.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: 19839570
• Report Number: 3004423487-2024-00014
• Device Sequence Number: 17862311
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): Y
• 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): 06/28/2024

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: 01/23/2025
• Device Model Number: 40083
• Device Lot Number: 23A182
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2023
• 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: 54 YR
• Patient Sex: Female