MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Tinnitus (2103); Discomfort (2330); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The date of incident was not provided to the manufacturer.

Event Description

The procedure was a submental treatment with tumescent anesthesia, manual undermining and j-plasma.Complications of subcutaneous lumps arose 7-8 weeks post the procedure and resulted in a visit to the er.Patient was diagnosed with possible abcess and put on antibiotics without culture.Fluid was aspirated by the office.Additional complication of air buildup resulted in the left eye swelling shut (resolved within in a few days without treatment) and patient reported popping and fullness in ears for several months.

• 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; clearwater, FL 33760-4004 ; 7273842323
• MDR Report Key: 8678522
• MDR Text Key: 147323245
• Report Number: 3007593903-2019-00009
• 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,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization