NEIVERT N4370 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-28 for NEIVERT N4370 * manufactured by Bausch & Lomb, Inc..

Event Text Entries

[18298709] The tip of the guarded osteotome broke off in the patient's right nare during the procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3608202
• MDR Report Key: 3608202
• Date Received: 2014-01-28
• Date of Report: 2014-01-28
• Date of Event: 2013-12-20
• Report Date: 2014-01-28
• Date Reported to FDA: 2014-01-28
• Date Reported to Mfgr: 2014-02-05
• Date Added to Maude: 2014-02-05
• 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: 3
• 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: NEIVERT
• Generic Name: OSTEOTOME
• Product Code: GFI
• Date Received: 2014-01-28
• Model Number: N4370
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAUSCH & LOMB, INC.
• Manufacturer Address: 499 SOVEREIGN CT. MANCHESTER MO 63011 US 63011

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-01-28