MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA

Model Number J-PLASMA

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Ulcer (2274); Injury (2348)

Event Date 03/28/2019

Event Type  Injury  

Event Description

Complaint for a right axillary skin ulcer.Post op exam was normal 2 days after surgery, ulcer developed 3 days after post op exam.The procedure included liposuction followed by renuvion cosmetic technology.Debridement for the ulcer was required.

• Brand Name: J-PLASMA
• Type of Device: J-PLASMA
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: april baures ; 5115 ulmerton road; cleawater, FL 33760-4004 ; 7273842323
• MDR Report Key: 8543341
• MDR Text Key: 142870737
• Report Number: 3007593903-2019-00002
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607151011871
• UDI-Public: 00607151011871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: J-PLASMA
• Device Catalogue Number: BVX-150-BPS
• Device Lot Number: 1118B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention