MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION; RENUVION J-PLASMA PRECISE OPEN HANDPIECE

Model Number	BVX-044-BPS
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dermal resurfacing is considered off label and is not included in the intended uses of the device involved.A letter was emailed to the customer regarding off label use of the device for dermal resurfacing that included risks to the patient.
Event or Problem Description
In the united states, the patient presented with a hypertrophic scar over the jawline approximately 3 cm by.5 cm due to a burn that appeared after a dermal resurfacing procedure.The doctor treated the patient with conservative therapies including steroid injections.Dermal resurfacing is an off label use of the device.There was no reported malfunction of the device.

• Brand Name: RENUVION
• Common Device Name: RENUVION J-PLASMA PRECISE OPEN HANDPIECE
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 11421839
• Report Number: 3007593903-2021-00003
• Device Sequence Number: 3243207
• Product Code: GEI
• UDI-Device Identifier: 00607151011864
• UDI-Public: 00607151011864
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: BVX-044-BPS
• Device Catalogue Number: BVX-044-BPS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention