BALLENGER SWIVEL KNIFE RH761

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 1998-05-27 for BALLENGER SWIVEL KNIFE RH761 manufactured by Allegiance Healthcare.

Event Text Entries

[85802] The blade on the knife fractured the first time used, on an ear, nose, throat, sinus cavity procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1423507-1998-00166
• MDR Report Key: 169317
• Report Source: 05,06
• Date Received: 1998-05-27
• Date of Report: 1998-05-27
• Date Mfgr Received: 1998-05-01
• Device Manufacturer Date: 1998-01-01
• Date Added to Maude: 1998-05-29
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• 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: EMF
• Date Received: 1998-05-27
• Returned To Mfg: 1998-05-20
• Model Number: RH761
• Catalog Number: RH761
• Lot Number: P
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 164695
• Manufacturer: ALLEGIANCE HEALTHCARE
• Manufacturer Address: 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US
• Baseline Brand Name: BALLENGER SWIVEL KNIFE
• Baseline Generic Name: SWIVEL KNIFE
• Baseline Model No: RH761
• Baseline Catalog No: RH761
• Baseline ID: NA
• Baseline Device Family: INSTRUMENT
• Baseline Shelf Life [Months]: NA
• 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	1998-05-27