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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2004-05-20 for * manufactured by *.

MAUDE Entry Details

• Report Number: 1416605-2004-00002
• MDR Report Key: 530338
• Report Source: 08
• Date Received: 2004-05-20
• Date of Event: 2004-05-05
• Date Mfgr Received: 2004-05-20
• Device Manufacturer Date: 2003-11-01
• Date Added to Maude: 2004-06-21
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: 3232 NORTH ROCKWELL ST
• Manufacturer City: CHICAGO IL 60618
• Manufacturer Country: US
• Manufacturer Postal: 60618
• 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: *
• Generic Name: *
• Product Code: EKB
• Date Received: 2004-05-20
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 519568
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-05-20