MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA HANDPIECE; GS-018C

Catalog Number	GS-018C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	08/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reporter notified of allegations of patient injuries from a j-plasma procedure in the face and neck area.Reporter confirmed that the patient had subsequent treatments such as: ipl and micro needling.No allegation of device malfunction.
Event or Problem Description
The event was notified be bovie medical sale representative.A face and neck resurfacing procedure was performed on patient who has since complained of scaring.

• Brand Name: J-PLASMA HANDPIECE
• Common Device Name: GS-018C
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 6200517
• Report Number: 3007593903-2016-00013
• Device Sequence Number: 13720845
• Product Code: GEI
• UDI-Device Identifier: 10607151007819
• UDI-Public: (01)10607151007819(17)200601(11)160607(10)0616G
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date (Section B): 12/22/2016

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: No Information
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: GS-018C
• Device Lot Number: 0616G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2016
• 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