MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC REVANESSE LIPS+ 1.2 ML

Model Number	PN40149
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	10/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 a patient received 0.4 cc of revanesse lips + into her lips.Prior to the treatment the patient received "iv vitamins" and had "a topical numbing ointment from empower pharmacy " applied to their lips, prior to injection.There were no documented concerns or adverse events at the time of injection.Three days later the patient noticed a "small oval shaped formation on the left upper lip" and was instructed to gently massage the area.There was no erythema, inflammation or nodules.The photos provided all clearly shown an area of superficial product deposition on the left upper lip.Eventually on (b)(6) 2024 the superficially injected product was dissolved with hyaluronidase.

• Brand Name: REVANESSE LIPS+ 1.2 ML
• Common Device Name: REVANESSE LIPS+ 1.2 ML
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC; 138 industrial parkway n; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES; 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: 20917905
• Report Number: 3004423487-2024-00027
• Device Sequence Number: 5068773
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P160042 S014
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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: 11/16/2025
• Device Model Number: PN40149
• Device Lot Number: 23K167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2024
• 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: 37 YR
• Patient Sex: Female
• Patient Race: White