MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA HANDPIECE; BVX-150-BPS

Model Number	BVX-150-BPS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The doctor advanced the blade to clear the handpiece and inadvertently she did not retracted full the blade causing a burn on the patient.Sale rep discussed the incident with doctor and she takes fully responsibility for advancing the blade and causing the burn.
Event or Problem Description
Reported complaint allege that the patient received a burn on the patient face/ jawline during a procedure.

• Brand Name: J-PLASMA HANDPIECE
• Common Device Name: BVX-150-BPS
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 7643523
• Report Number: 3007593903-2018-00030
• Device Sequence Number: 14008657
• Product Code: GEI
• UDI-Device Identifier: 10607151011878
• UDI-Public: (01)10607151011878(17)19100(10)0418C
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

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: Physician
• Device Expiration Date: 10/01/2019
• Device Model Number: BVX-150-BPS
• Device Catalogue Number: BVX-150-BPS
• Device Lot Number: 0418C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 70 YR