MAUDE Adverse Event Report: BOVIE MEDICAL CORP MCKESSON; DISPOSABLE SOLID GROUNDING PAD

Model Number	22-ESRSC
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There have been a total of 171,200 sold of this disposable pad with 2 complaints recorded for similar occurrences.This results in a 0.001% complaint rate for this occurrences.We are still investigating with the customer to determine root cause and the device history record for this lot number is being reviewed.A follow up report will be submitted once the investigation is complete or we receive any significant additional information.
Event or Problem Description
The customer alleged that after the procedure was completed and the grounding pad was removed, it was noted that the patient's skin was burned on the right thigh in two areas.It was determined that the patient had acquired second and third degree burns.The burns have required multiple surgeries since and the patient was additionally hospitalized as a result.
Additional Manufacturer Narrative
We believe the following characteristics of this event have contributed to this burn: it was found through inspection of the pictures of the used pad that blood and other fluids have come into contact with the return grounding pad.This has allowed the pad to lose contact with the patients skin, thus causing arcing/burning.The customer could not confirm activation times of the handpiece.Based on this information, this can been seen as the final report.If additional information is received that alleges additional patient involvement or need for corrective actions, a follow up report will be submitted.

• Brand Name: MCKESSON
• Common Device Name: DISPOSABLE SOLID GROUNDING PAD
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton rd; clearwater FL 33760
• MDR Report Key: 11251197
• Report Number: 3007208013-2021-00006
• Device Sequence Number: 3583575
• Product Code: GEI
• UDI-Device Identifier: 10612479209227
• UDI-Public: 10612479209227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: Health Professional
• Device Expiration Date: 01/13/2023
• Device Model Number: 22-ESRSC
• Device Catalogue Number: 22-ESRSC
• Device Lot Number: 2020-01-13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 03/12/2021
• 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: Hospitalization; Required Intervention