MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA + (WITH LIDOCAINE) 1.0ML

Model Number	PN40082
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Wrinkling (2613)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product lot number has been verified and has been confirmed to be released by the company.The batch record, qc test reports, and training of staff were analysed and it has been determined that product is within required specifications and manufactured according to appropriate procedures.The lot number 21k188 was verified and has been confirmed to be released by the company.The batch record, qc test reports, and training of staff were analysed and it had been determined that product is within required specifications, and manufactured according to the appropriate procedures.The batch records and rest of the reports for this lot had passed all tests and a check of the ncr log for this lot number has produced zero results for this lot number.The check on the deviation log had produced zero results for this lot number as well.The certificate of analysis (coa) of this lot shows that all testing performed on the product has passed.No other clinical complaint was found associated with this lot 21k188.
Event or Problem Description
Adverse event information: based on the information provided, the medical doctor injected herself on (b)(6) 2019, with revanesse versa + (w/ lidocaine) 1.0ml pn40082, lot # 19f071 in the left and right jaw area with i syringe injected per side (1.0ml volume per side).Injector in this case as mentioned is the medical doctor md, 20 years experience.Topical anaesthetic blt was used.No medications before treatment.The doctor reports experiencing redness and unresolved bumps on the left side of her face that persists 3 years later.Right side is unaffected.Clinic had provided prollenium with photographs of the adverse event on request.When manufacturer reached out for further information on patient status, doctor reported that bumps have reduced but still showing.Clinic had provided prollenium with photographs of the adverse event on request.The manufacturer initiated the investigation by conducting a review of its internal records associated with the batch.In addition, a review from the company's medical director was sought.Internal report number (b)(4).

• Brand Name: REVANESSE VERSA + (WITH LIDOCAINE) 1.0ML
• Common Device Name: REVANESSE VERSA + (WITH LIDOCAINE) 1.0ML
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway north; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway north; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway north; aurora L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 15974325
• Report Number: 3004423487-2022-00062
• Device Sequence Number: 17882633
• Product Code: LMH
• UDI-Device Identifier: 10669808001014
• UDI-Public: 10669808001014
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160042 S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 12/12/2022

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
• Device Model Number: PN40082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2019
• 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
• Patient Age: 62 YR
• Patient Sex: Female