MAUDE Adverse Event Report: SHENB VIVACE; RADIOFREQUENCY MICRONEEDLING SYSTEM

Model Number	VIVACE
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient received facial treatments of filler and neuromodulators 4 weeks prior to the vivace treatment.The treatment resulted in the filler and neuromodulators melting away, leaving the patient's face sagging.The provider had planned a series of treatments with the vivace device and included a treatment for injections between the first and second vivace treatments.Vivace treatment one was performed on (b)(6) 2020.The filler injections were performed (b)(6) 2020.The second vivace treatment was the subject of this report, performed on (b)(6) 2020.

• Brand Name: VIVACE
• Common Device Name: RADIOFREQUENCY MICRONEEDLING SYSTEM
• Manufacturer (Section D): SHENB; shenb bldg. 148, seongsui-ro; seongdong-gu; seoul, ; KS
• MDR Report Key: 10857615
• Report Number: 3012204368-2020-00001
• Device Sequence Number: 17131044
• Product Code: OUH
• UDI-Device Identifier: 08800017100326
• UDI-Public: 08800017100326
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/17/2020
• Report Date (Section F): 11/17/2020

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 Model Number: VIVACE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/05/2020
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOTOX - ALLERGAN, VERSA HA FILLER - REVANESSE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 54
• Date Report Sent to FDA: 11/17/2020