BOVIE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-03 for BOVIE * manufactured by Deroyal.

Event Text Entries

[199976] Surgery in progress for tonsillectomy. Surgeon noted tip of bovie had started to flame up and burn tip. No known injury to pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 299462
• MDR Report Key: 299462
• Date Received: 2000-10-03
• Date of Report: 2000-09-05
• Date of Event: 2000-09-01
• Date Facility Aware: 2000-09-01
• Report Date: 2000-09-05
• Date Reported to Mfgr: 2000-09-05
• Date Added to Maude: 2000-10-12
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BOVIE
• Generic Name: BOVIE TIP
• Product Code: MMO
• Date Received: 2000-10-03
• Model Number: *
• Catalog Number: *
• Lot Number: T&A CUSTOM KIT 489193
• ID Number: REF #: 50-3895.15
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 289864
• Manufacturer: DEROYAL
• Manufacturer Address: 200 DEROYAL LN POWELL TN 37849 US
• Baseline Brand Name: T & A CUSTOM KIT
• Baseline Generic Name: CUSTOM PROCEDURAL TRAY
• Baseline Model No: NA
• Baseline Catalog No: 50-3895
• Baseline ID: NA
• Baseline Device Family: TRAY SURGICAL ENT
• Baseline Shelf Life Contained: N
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-10-03