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

Model Number	40083
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At some time approximately 27 months earlier at patient received " revanesse versa" (unconfirmed as no lot # was provided) into her lips by an rn.There were no recorded adverse events or concerns.Two years and 3 months later the patient noticed a small non inflamed ridge on her everted, inner, upper lip.The ridge was on the mucosa in line with the occlusion of the teeth.The line even had gaps corresponding to the spaces between the patient's teeth.The injector described the patient as "under stress".There was no medical director documented on the ae notification forms which suggests the patient did not have a medical assessment for her concern.My clinical opinion is that this does not represent an have adverse event.The line on the mucosa of the upper lip is the classic appearance seen when someone habitually bites onto their lip.This is a very common finding and occurs more often when individuals are nervous or stressed.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: 20286458
• Report Number: 3004423487-2024-00018
• Device Sequence Number: 20658203
• 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
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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
• Device Model Number: 40083
• 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: 08/23/2024
• Initial Report FDA Received Date: 09/23/2024
• 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
• Patient Sex: Female