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

Model Number	PN40083
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating np's account: "slight discoloration noted at injection area of pyriform fossa and nose.Pt dissolved day of injection.Further dissolved next 2 days.Meds prescribed: medrol, clindamycin, keflex, asa, viagra, nitropaste and warm compresses used.As of (b)(6) client reports it has resolved.Unsure if this was a vascular compression vs occlusion.No specific site found impairing blood flow on 2 different ultrasounds." prollenium medical technologies inc.: "the following is a clinical opinion based on the information provided in case (b)(4).On (b)(6) 2024 a patient had revanesse versa+ injected into their nose and pyriform fossa.Compounded blt topical anesthetic was applied prior to injection.The np injector noticed "discolouration" in the area of injection, so the area was treated as a vascular compromise and the product was "dissolved".The discolouration resolved.No other history or photos were provided.My clinical opinion is that this case represents a case of vascular occlusion which was treated successfully by dissolving the product.".

• Brand Name: REVANESSE VERSA+ 1.2 ML
• Common Device Name: REVANESSE VERSA+ 1.2 ML
• 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: 20727243
• Report Number: 3004423487-2024-00025
• Device Sequence Number: 12860943
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160042 S004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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: 04/02/2026
• Device Model Number: PN40083
• Device Lot Number: 24D136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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: 62 YR
• Patient Sex: Female