MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Scarring (2061); Injury (2348); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

Patient received a burn after a j-plasma procedure that resulted in scarring.

• Brand Name: J-PLASMA
• Type of Device: J-PLASMA
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater, fl
• Manufacturer Contact: april baures ; 5115 ulmerton road; clearwater, fl ; 3842323855
• MDR Report Key: 9828551
• MDR Text Key: 183374169
• Report Number: 3007593903-2020-00008
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability