MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA

Model Number	J-PLASMA
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported complaint for acute right chest wall hematoma following surgery.Blood pressure upon presentation was 190/110.Right chest wall was evacuated of a 350cc hematoma.

• Brand Name: J-PLASMA
• Common Device Name: J-PLASMA
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater 33760 4004
• MDR Report Key: 8613029
• Report Number: 3007593903-2019-00006
• Device Sequence Number: 2003445
• Product Code: GEI
• UDI-Device Identifier: 00607151011871
• UDI-Public: 00607151011871
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

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 Expiration Date: 01/09/2022
• Device Model Number: J-PLASMA
• Device Catalogue Number: BVX-150B
• Device Lot Number: 0918E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• 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: Required Intervention
• Patient Age: 54 YR