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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 report with the FDA on 2003-07-23 for * manufactured by *.

MAUDE Entry Details

• Report Number: 2250051-2003-00319
• MDR Report Key: 473990
• Report Source: 05
• Date Received: 2003-07-23
• Date of Event: 2003-07-15
• Date Mfgr Received: 2001-11-20
• Date Added to Maude: 2003-07-29
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: NANCY PAPCIAK
• Manufacturer Street: 1001 US HWY 202
• Manufacturer City: RARITAN NJ 088690606
• Manufacturer Country: US
• Manufacturer Postal: 088690606
• Manufacturer Phone: 9087043872
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: *
• Product Code: GHM
• Date Received: 2003-07-23
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 462842
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-07-23