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

Model Number	PN40083
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Dry Skin (4839)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Based on the information/report provided by the clinic, a female (the dob was not disclosed) was injected with revanesse versa+(with lidocaine) in lips on (b)(6) 2023.Around or at (b)(6) 2024, the patient contacted the clinic and reported experiencing excessive dryness and cracking lips.No information about the patient [race, previous medical history), injection (injection plan, location, amount of injection, medical condition of patient during the injection) and post care has been provided despite of several requests by prollenium through email [6-feb-2024, 12-feb-2024,15-feb-2024,20-feb-2024,26-feb-2024,29-feb-2024], phone call and sending a 30-day-notice letter through email [29-feb-2024].No images of the patient lips after and before the injection have been provided.The batch record, qc test reports (30-may-2023), and qc final inspection review check list (12-jun-2023) 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 22h103 was verified and has been confirmed to be released by the company.The information provided by the clinic has been submitted to the prollenium medical director for review.The medical director's opinion about the reported ae is as follows: "the following is a clinical opinion based on the sparce information provided by the clinic in case (b)(4).On (b)(6) 2023 a patient may have been injected with revanesse versa +.No information about the treatment such as location, amount, treatment plan, post care, other products or patient history was provided.On or around (b)(6) 2024 the patient told the injector that they "experienced dryness and cracking of their lips".No photos or additional information or history was provided.Despite repeated requests by phone and email, there is not enough information to form a clinical opinion on why the patient has chapped lips.I see no information or evidence to support an adverse event in this case.Internal prollenium complaint number: (b)(4).
Additional Manufacturer Narrative
The batch record, qc test reports (30-may-2023), and qc final inspection review check list (12-jun-2023) 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 23e177 was verified and has been confirmed to be released by the company.

• 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; 38 industrial pkwy n; auroa, 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: 18856929
• Report Number: 3004423487-2024-00004
• Device Sequence Number: 8282414
• 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: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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: 05/16/2025
• Device Model Number: PN40083
• Device Lot Number: 21E177
• 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: 02/05/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2023
• 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 Sex: Female