BALLENGER SWIVEL KNIFE RH762

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-04-22 for BALLENGER SWIVEL KNIFE RH762 manufactured by Allegiance Healthcare Corp..

Event Text Entries

[55287] Account reported that during use, the blade of the knife broke off in the pt's nose. Unable to retrieve. No untoward effects to the pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1423537-1997-00068
• MDR Report Key: 85339
• Report Source: 05,06
• 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 Reported to FDA: 1997-04-24
• Date Reported to Mfgr: 1997-04-02
• Date Mfgr Received: 1997-04-02
• Device Manufacturer Date: 1989-01-01
• Date Added to Maude: 1997-04-23
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BALLENGER SWIVEL KNIFE
• Generic Name: SWIVEL KNIFE
• Product Code: KTG
• Date Received: 1997-04-22
• Model Number: RH762
• Catalog Number: RH762
• Lot Number: X
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 8 YR
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 84543
• Manufacturer: ALLEGIANCE HEALTHCARE CORP.
• Manufacturer Address: 1500 WAUKEGAN RD BLDG K 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	1. Other	1997-04-22