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

Model Number	PN40083
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nodule (4551)
Type of Reportable Event	Serious Injury
Event or Problem Description
Adverse event information: the injector reports to that the patient was injected with revanesse versa+ (with lidocaine) 1.2ml,21e014 on (b)(6) 2022 on the versa, 0.3ml of product was injected.The patient reports to the injector that she has developed bumps on her lips a year later.Prollenium medical technologies inc.Was not able to consult its medical director owing to the lack of information provided.Prollenium medical technologies inc.Was not able to consult its medical director owing to the lack of information provided.

• Brand Name: REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML
• Common Device Name: REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway north; aurora, on L4G 4 C3; CA L4G 4C3
• 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: 19924214
• Report Number: 3004423487-2024-00017
• Device Sequence Number: 2725334
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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: 04/06/2023
• Device Model Number: PN40083
• Device Lot Number: 21E014
• 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: 07/02/2024
• Initial Report FDA Received Date: 08/06/2024
• 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
• Outcome Attributed to Adverse Event: Other; Other
• Patient Sex: Female