BALLENGER SWIVEL KNIFE RH-761 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-31 for BALLENGER SWIVEL KNIFE RH-761 * manufactured by Cardinal Health.

Event Text Entries

[311607] Nasal knife had swivel tip break off during procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 550877
• MDR Report Key: 550877
• Date Received: 2004-03-31
• Date of Report: 2004-03-31
• Date of Event: 2003-12-08
• Report Date: 2004-03-31
• Date Reported to FDA: 2004-03-31
• Date Added to Maude: 2004-10-26
• 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: BALLENGER SWIVEL KNIFE
• Generic Name: NASAL KNIFE
• Product Code: KTG
• Date Received: 2004-03-31
• Model Number: RH-761
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 540391
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: UNKNOWN 1430 WAUKEGAN RD. MCGAW PARK IL 60085 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-03-31