IMPRA F8006 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-09 for IMPRA F8006 * manufactured by Impra.

Event Text Entries

[107240] Dialysis graft placed 10/30/96. 11/17 pt presents with pain at graft site. To or, exploration of graft on 11/17 showed considerable deterioration with intimal hyperplasia. Device removed and replaced with another brand.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 148457
• MDR Report Key: 148457
• Date Received: 1998-01-09
• Date of Report: 1997-11-25
• Date of Event: 1997-11-17
• Date Facility Aware: 1997-11-17
• Report Date: 1997-11-26
• Date Reported to Mfgr: 1997-11-26
• Date Added to Maude: 1998-02-13
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IMPRA
• Generic Name: VASCULAR ACCESS DEVICE FOR DIALYSIS
• Product Code: MCI
• Date Received: 1998-01-09
• Model Number: F8006
• Catalog Number: *
• Lot Number: CEO3 4
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: 1 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 144667
• Manufacturer: IMPRA
• Manufacturer Address: P.O. BOX 75767 CHARLOTTE NC 28275 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-01-09