BALENGER SWIVEL KNIFE 7 3/4" LONG/3MM WIDE RH 762

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-22 for BALENGER SWIVEL KNIFE 7 3/4" LONG/3MM WIDE RH 762 manufactured by Allegiance V Mueller.

Event Text Entries

[58315] During use, blade of swivel knife broke off in pt's nose. Unable to be retrieved. No known untoward effects to pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 85310
• MDR Report Key: 85310
• Date Received: 1997-04-22
• Date of Report: 1997-03-21
• Date of Event: 1997-03-17
• Date Facility Aware: 1997-03-17
• Report Date: 1997-03-21
• Date Added to Maude: 1997-04-23
• 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: BALENGER SWIVEL KNIFE
• Generic Name: SURGICAL SWIVEL KNIFE
• Product Code: KTG
• Date Received: 1997-04-22
• Model Number: 7 3/4" LONG/3MM WIDE
• Catalog Number: RH 762
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 84543
• Manufacturer: ALLEGIANCE V MUELLER
• Manufacturer Address: 1500 WAUKEGAN RD MCGAW PARK IL 60085 US
• Baseline Brand Name: BALLENGER SWIVEL KNIFE
• Baseline Generic Name: SWIVEL KNIFE
• Baseline Model No: RH762
• Baseline Catalog No: RH762
• Baseline ID: NA
• Baseline Device Family: KNIFE
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: *
• 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		1997-04-22