CT CONTRAST MEDIA *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-17 for CT CONTRAST MEDIA * manufactured by Unk.

Event Text Entries

[17511899] At end of an abdominal ct, pt developed rash on her chest and also felt that her breathing was becoming a little difficult. At this time pt was given 50 mg benadryl iv. As a result, her symptomatology disappeared.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1010083
• MDR Report Key: 43170
• Date Received: 1996-10-17
• Date of Report: 1995-05-15
• Date of Event: 1995-04-24
• Date Added to Maude: 1996-10-21
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CT CONTRAST MEDIA
• Generic Name: COMPUTED CONTRAST MEDIA TOMOGRAPHY
• Product Code: KTA
• Date Received: 1996-10-17
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 44141
• Manufacturer: UNK
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		1996-10-17