MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA HANDPIECE; GS HANDPIECE, OPEN PROCEDURE

Catalog Number GS-018C

Device Problem Failure to Obtain Sample (2533)

Patient Problem Burn, Thermal (2530)

Event Date 01/15/2016

Event Type  Injury  

Manufacturer Narrative

Patient received hypertrophic scarring after procedure with j-plasma (b)(4).Date of incident was (b)(6) 2016 and bovie medical was notified on (b)(6) 2016.Procedure was for j-plasma on the eye, cheeks, peri-oval.Condition of patient after procedure is hypertrophic scarring to cheeks bilateral.Treatments to patient included: three skin pen treatments, two kenalog steroid injections.Patient information: (b)(6) yr.Old female.Handpiece has already been disposed of, no product is available for evaluation.Two attempts were made to obtain additional information without any responses as of this report date.A root cause cannot be determined at this time, no product is available for evaluation, there is no reporter indication of device malfunction.The severity of the scar is unknown at this time.Device was disposed of by the user.

Event Description

Patient received hypertrophic scarring after procedure with j-plasma (b)(4).

• Brand Name: J-PLASMA HANDPIECE
• Type of Device: GS HANDPIECE, OPEN PROCEDURE
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer (Section G): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: julie mcdonald ; 5115 ulmerton road; clearwater, FL 33760-4004
• MDR Report Key: 5919251
• MDR Text Key: 53658741
• Report Number: 3007593903-2016-00009
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nursing Assistant
• Type of Report: Initial
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: GS-018C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other