MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML

Model Number	PN40083
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Adverse event information: based on the initial information provided by the clinic, the patient was injected with revanesse versa+ (with lidocaine) 1.2 ml pn40083, lot number 22l122 on (b)(6) 2023 with 1.0ml of versa on the lips.The patient started to experience unilateral lip swelling, 15 days post injection.Prior to treatment blt cream was used.The clinic informed the manufacturer, that the patient was given doxycyclene 100mg bid for a week and the swelling had not resolved, so the patient was brought back to the clinic was given a vial of hylenex to dissolve the filler.Follow up communications with clinic: following receipt of initial report, manufacturer has reached out to the clinic for addition information pertaining to the reported adverse incident.This information is required for prollenium's medical director to make a suitable medical assessment of the case presented.

• Brand Name: REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML
• Common Device Name: REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway north; aurora, on L4G4C 3; CA L4G4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC; 138 industrial parkway north; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway north; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 18012126
• Report Number: 3004423487-2023-00039
• Device Sequence Number: 20661592
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: User Facility
• Initial Reporter Occupation: Physician Assistant
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 10/25/2023

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: PN40083
• Device Lot Number: 22L122
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/26/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Race: White