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	Swelling/ Edema (4577)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a patient was injected with 0.4 ml of lot 22l122, revanesse versa+ ha filler into their undereye area.Prollenium medical technologies inc.Has contacted the clinic four times via email and phone (11-may-2023 18-may-2023, 24-may-2023, 12-jun-2023) to obtain additional information associated with the reported adverse event.The clinic did not respond.Prollenium medical technologies inc.Will continue the investigation.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: 17113338
• Report Number: 3004423487-2023-00022
• Device Sequence Number: 20419501
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2023

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: 12/14/2024
• Device Model Number: 40083
• Device Lot Number: 22L122
• 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: 05/11/2023
• Initial Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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: 33 YR
• Patient Sex: Female