OMNI SCAN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-06 for OMNI SCAN * manufactured by Ge - Amerstram.

Event Text Entries

[17254327] Pt had an mri with 13 ml contrast in 2006. All 3 patients have subsequently been diagnosed with nephrogenic systemic fibrosis. Fda sent out an alert in 12/06 concerning this condition.
Patient Sequence No: 1, Text Type: D, B5

[17303039] Pt had an mri with contrast (30 ml) in 2006. All 3 pts have subsequently been diagnosed with nephrogenic systemic fibrosis. Fda sent out an alert in 12/06 concerning this condition.
Patient Sequence No: 2, Text Type: D, B5

[17339006] Pt had an mri/mra with 30-40 ml contrast on 2 exams. All three pts have subsequently been diagnosed with nephrogenic systemic fibrosis. Fda sent out an alert in dec 2006 concerning this condition.
Patient Sequence No: 3, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1042539
• MDR Report Key: 837173
• Date Received: 2007-04-06
• Date of Report: 2007-04-06
• Date Added to Maude: 2007-04-16
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: OMNI SCAN
• Generic Name: MRI
• Product Code: KTA
• Date Received: 2007-04-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 824477
• Manufacturer: GE - AMERSTRAM
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: CONTRAST MEDIA
• Generic Name: MEDIA INJECTABLE
• Product Code: LNH
• Date Received: 2007-04-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 824493
• Manufacturer: GE - AMERSTRAM
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-04-06
2	0		2007-04-06
3	0		2007-04-06