MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA

Catalog Number	BVX-044-BPP
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Codes	Skin Discoloration (2074); Injury (2348)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is considered an off label use of the device.The device is intended to be used for electrosurgical cutting, coagulation, and ablation of soft tissue during open surgical procedures.
Event or Problem Description
Two weeks after facial resurfacing, the patient began experiencing additional inflammation, redness, discoloration and increased pain and sensitivity of the face.

• Brand Name: J-PLASMA
• Common Device Name: J-PLASMA
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 8712686
• Report Number: 3007593903-2019-00010
• Device Sequence Number: 2522301
• Product Code: GEI
• UDI-Device Identifier: 00607151011918
• UDI-Public: 00607151011918
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

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 Catalogue Number: BVX-044-BPP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/19/2019
• 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: Disability