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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 05,06 report with the FDA on 2003-10-27 for * manufactured by *.

MAUDE Entry Details

• Report Number: 9610617-2003-00022
• MDR Report Key: 493348
• Report Source: 05,06
• Date Received: 2003-10-27
• Date of Event: 2003-09-30
• Date Added to Maude: 2003-11-05
• 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: MITTLESTRASSE 8 POSTFACH 230
• Manufacturer City: TUTTLINGEN 78503
• Manufacturer Country: GM
• Manufacturer Postal: 78503
• 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: EZO
• Date Received: 2003-10-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 482053
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-10-27