MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES, AURORA, ON REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML

Model Number	PN40083
Medical Device Problem Codes	No Apparent Adverse Event (3189); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient recounted a narrative that the she was injected with revanesse versa.Her account indicated that she was treated in the marionette lines, nasolabial folds and chin and reported scarring.No clinic medical director narrative was provided.No images were provided.No treatment plan, nor medical history was provided.Prollenium has requested supplemental information on four occasions.Prollenium plans to follow up with supplemental requests for the relevant information with which our investigation can proceed.
Additional Manufacturer Narrative
The clinic has not provided us with the requested information.The clinic says they have not written anything down.No information, no treatment, no injection information, etc.Have been recorded by the clinic.The clinic and patient have not provided any images, so far.
Event or Problem Description
The clinic has provided images of pre- and post-treatment with further information on their company letterhead on (b)(6) 2024.
Additional Manufacturer Narrative
Some information provided in this follow up-1 report are additional information; some are correction; the corrections are the adverse event problem codes (section h.6), and manufacturer report number.

• Brand Name: REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML
• Common Device Name: REVANESSE VERSA+ (WITH LIDOCAINE)
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES, AURORA, ON; 138 industrial parkway n; aurora, on L4G 4 C3,; CA L4G 4C3,
• Manufacturer (Section G): 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: 18766491
• Report Number: 3004423487-2024-00002
• Device Sequence Number: 7701318
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: Other
• Device Expiration Date: 03/21/2025
• Device Model Number: PN40083
• Device Lot Number: 23C209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 55 YR
• Patient Sex: Female
• Patient Race: White