BIOLASE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-29 for BIOLASE * manufactured by Biolase.

Event Text Entries

[20888229] Root surface of tooth treated with dental laser appeared brown, possible burn to root. This could be seen with a perioscope. Reporter has a copy of video. This occurring during "laser curettage. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1028260
• MDR Report Key: 456747
• Date Received: 2003-04-29
• Date of Report: 2003-04-29
• Date of Event: 2002-11-01
• Date Added to Maude: 2003-05-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOLASE
• Generic Name: DENTAL LASER
• Product Code: LYB
• Date Received: 2003-04-29
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 445740
• Manufacturer: BIOLASE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-04-29