PROSORBA COLUMN 9798701

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 2006-05-16 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.

Event Text Entries

[459188] Pt admitted to hosp with "cvc" infection after 5th pc treatment. She was treated with antiobiotics, "cvc" removed and discharged, no further prosorba planned.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3032792-2006-00004
• MDR Report Key: 715624
• Report Source: 05
• Date Received: 2006-05-16
• Date of Report: 2006-05-16
• Date of Event: 2006-04-13
• Report Date: 2006-05-16
• Date Mfgr Received: 2006-04-20
• Device Manufacturer Date: 2005-07-01
• Date Added to Maude: 2006-05-19
• 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: 3
• Manufacturer Contact: JOSHUA LASKER
• Manufacturer Street: 14715 NE 95TH ST, SUITE 100
• Manufacturer City: REDMOND WA 98052
• Manufacturer Country: US
• Manufacturer Postal: 98052
• Manufacturer Phone: 4252422154
• 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: PROSORBA COLUMN
• Generic Name: IMMUNOADSORPTION COLUMN
• Product Code: LQQ
• Date Received: 2006-05-16
• Model Number: 9798701
• Catalog Number: 9798701
• Lot Number: RGN001A
• ID Number: NA
• Device Expiration Date: 2007-01-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 9 MO
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 704694
• Manufacturer: FRESENIUS HEMOCARE
• Manufacturer Address: * REDMOND WA * US
• Baseline Brand Name: PROSORBA COLUMN
• Baseline Generic Name: IMMUNOADSORPTION COLUMN
• Baseline Model No: 9798701
• Baseline Catalog No: 9798701
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2006-05-16