*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2005-10-19 for * manufactured by Fresenius Medical Care-north America.

MAUDE Entry Details

• Report Number: 2937457-2005-00015
• MDR Report Key: 642604
• Report Source: 00,06
• Date Received: 2005-10-19
• Date of Event: 2005-09-02
• Date Mfgr Received: 2005-09-20
• Device Manufacturer Date: 2002-01-01
• Date Added to Maude: 2005-10-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: ELVY DIZON, BSN, RN, CNN
• Manufacturer Street: 2637 SHADELANDS DRIVE
• Manufacturer City: WALNUT CREEK CA 94598
• Manufacturer Country: US
• Manufacturer Postal: 94598
• Manufacturer Phone: 8002272572
• 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: *
• Product Code: FIL
• Date Received: 2005-10-19
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 626473
• Manufacturer: FRESENIUS MEDICAL CARE-NORTH AMERICA
• Manufacturer Address: 2637 SHEDLANDS DR. WALNUT CREEK CA 94598 US
• Baseline Brand Name: FRESENIUS DIALYSIS DELIVERY SYSTEM
• Baseline Generic Name: HEMODIALYSIS MACHINE
• Baseline Model No: 2008K
• Baseline Catalog No: F002-40
• Baseline ID: NA
• Baseline Device Family: NA
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K994267
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-10-19