*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-06-17 for * manufactured by Allegiance/b. Mueller.

Event Text Entries

[155799] During tonsillectomy, the snare appeared to break (length was verified against new wire and x-rays negative).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 230882
• MDR Report Key: 230882
• Date Received: 1999-06-17
• Date of Report: 1999-04-15
• Date of Event: 1999-02-26
• Date Facility Aware: 1999-02-26
• Report Date: 1999-03-23
• Date Reported to Mfgr: 1999-04-15
• Date Added to Maude: 1999-07-09
• 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: *
• Generic Name: *
• Product Code: KBZ
• Date Received: 1999-06-17
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: CUST# 10004354
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 223835
• Manufacturer: ALLEGIANCE/B. MUELLER
• Manufacturer Address: 1430 WAUKEGAN RD. MCGAW PARK IL 60085 US
• Baseline Brand Name: WIRE, TONSIL, SNARE #7
• Baseline Generic Name: INSTRUMENT
• Baseline Model No: MO2010-007
• Baseline Catalog No: MO2010-007
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-06-17