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

Model Number	PN40083
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The retrospective review of the batch file shows that no element could explain these issues.The lot number 22f077 was verified and has been confirmed to be released by the company.As per the information provided, prollenium considers the reported ae as a pending assessment with no ae due to the product.The information provided by the patient has been submitted to the prollenium medical director for review.
Event or Problem Description
Based on the information/report provided by a patient through answer connect and later by the clinic, she was injected with a 1.2 ml revanesse versa+ (with lidocaine) in lips.Topical lidocaine 23% teracaine 7% was applied before the injection.8 hours later, the patient claimed that she got lumps in her lips and sent some images.The patient would not come back for a follow-up appointment.The patient also commented that she had a lump in her lip from previous injection.The patient stated that she has gone to another injector to have hyaluronidase injected.She has had one session of hylenex injected and feels most of the lumps are gone after this one treatment.The batch record, qc test reports (10-jun-2022), and qc final inspection review check list (20-jun-2022) were analyzed and it has been determined that the product was released within final release specifications.The retrospective review of the batch file shows that no element could explain these issues.The lot number 22f077 was verified and has been confirmed to be released by the company.As per the information provided, prollenium considers the reported ae as a pending assessment with no ae due to the product.The information provided by the patient has been submitted to the prollenium medical director for review.The prolleium medical director's clinical opinion will be submitted in the follow-up report.Internal prollenium complaint number: (b)(4).

• 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 n.; aurora, on L4G4C 3; CA L4G4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 indutrial parkway n.; aurora, on L4G4C 3; CA L4G4C3
• Manufacturer Contact: ario ; 138 industrial parkway n.; aurora, on L4G4C-3
• MDR Report Key: 18340939
• Report Number: 3004423487-2023-00043
• Device Sequence Number: 6702997
• 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
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 12/05/2023

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: 06/01/2024
• Device Model Number: PN40083
• Device Lot Number: 22F077
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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: 37 YR
• Patient Sex: Female
• Patient Race: White