MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA

Model Number	J-PLASMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hematoma (1884); Injury (2348)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint for a subcutaneous hematoma on left chest after surgery.Aspiration performed with no return of fluid.

• Brand Name: J-PLASMA
• Common Device Name: J-PLASMA
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; cleawater FL 33760 4004
• MDR Report Key: 8612136
• Report Number: 3007593903-2019-00007
• Device Sequence Number: 11267986
• Product Code: GEI
• UDI-Device Identifier: 00607151010140
• UDI-Public: 00607151010140
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151325
• 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): 05/14/2019

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 Expiration Date: 03/01/2022
• Device Model Number: J-PLASMA
• Device Catalogue Number: BVX-150B
• Device Lot Number: 0318B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/15/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 53 YR