GE HEALTHCARE OMNIPAQUE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-31 for GE HEALTHCARE OMNIPAQUE * manufactured by Ge Healthcare.

Event Text Entries

[581549] Physician called to report possibly contaminated ingestable. Product was used on pt and on the same night the pt returned to the hosp and was diagnosed with bacterial meningitis. Dr called the drug company who stated that there had been problems with omnipaqe 240.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4004271
• MDR Report Key: 811349
• Date Received: 2007-01-31
• Date of Report: 2006-11-07
• Date of Event: 2006-11-02
• Date Added to Maude: 2007-02-05
• 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 Details

• Brand Name: GE HEALTHCARE OMNIPAQUE
• Generic Name: *
• Product Code: KTA
• Date Received: 2007-01-31
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 798835
• Manufacturer: GE HEALTHCARE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-01-31