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

Model Number	22-ESRSC
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device involved in the incident is not available for return as it is being held by the hospital's risk management.Pictures were provided of the pads after the burn occurred.Upon review of the pictures, it was noted there was a significant amount of hair in the burn residue on the pads.Per the product ifu, all hair should be shaved from the selected site of the pad.This is the first complaint received for this occurrence with (b)(4) sold of all lots.Based on the above information, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information pertinent to the investigation, a follow up report will be submitted.
Event or Problem Description
The customer alleged the patient received a significant burn underneath a bovie pad.

• Brand Name: BOVIE
• Common Device Name: SOLID DISPOSABLE RETURN PAD
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 16099370
• Report Number: 3007208013-2023-00002
• Device Sequence Number: 6512029
• Product Code: GEI
• UDI-Device Identifier: 20612479209231
• UDI-Public: 20612479209231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K092761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/04/2022

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: 05/03/2025
• Device Model Number: 22-ESRSC
• Device Catalogue Number: 22-ESRSC
• Device Lot Number: CEG2E002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown