TM300 TRACTION SYSTEM A501009

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-12-08 for TM300 TRACTION SYSTEM A501009 manufactured by Ito, Inc.

MAUDE Entry Details

• Report Number: 1418324-2006-00002
• MDR Report Key: 805536
• Date Received: 2006-12-08
• Date of Report: 2006-12-07
• Date of Event: 2004-07-06
• Report Date: 2006-12-07
• Date Reported to FDA: 2006-12-07
• Date Reported to Mfgr: 2006-12-07
• Date Added to Maude: 2007-01-18
• 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: 3
• Reporter Occupation: ATTORNEY
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Manufacturer Phone: **
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TM300 TRACTION SYSTEM
• Generic Name: TM300 TRACTION SYSTEM
• Product Code: ITH
• Date Received: 2006-12-08
• Model Number: TM300
• Catalog Number: A501009
• Lot Number: N/A
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 1.5 YR
• Device Eval'ed by Mfgr: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 793050
• Manufacturer: ITO, INC
• Manufacturer Address: * NERIMA-KU, TOKYO JA
• Baseline Brand Name: TM300 TRACTION SYSTEM
• Baseline Generic Name: TM300 TRACTION SYSTEM
• Baseline Model No: TM300
• Baseline Catalog No: A501009
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2006-12-08