MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION JPLASMA

Catalog Number	BVX-150-BPP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Injury (2348); Patient Problem/Medical Problem (2688)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient received a burn on the neck after a liposuction procedure followed by renuvion.

• Brand Name: JPLASMA
• Common Device Name: JPLASMA
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 9411289
• Report Number: 3007593903-2019-00031
• Device Sequence Number: 17194149
• Product Code: GEI
• UDI-Device Identifier: 00607151011925
• UDI-Public: 00607151011925
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183610
• 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): 12/05/2019

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-150-BPP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/04/2019
• 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