MAUDE Adverse Event Report: BOVIE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problem Use of Device Problem (1670)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  malfunction  

Event Description

Bovie was hidden by drapes not visible patient suffered burnt to left upper arm.Lot # 769678.Fda safety report id # (b)(4).

• Brand Name: BOVIE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• MDR Report Key: 14789341
• MDR Text Key: 294806137
• Report Number: MW5110478
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Male