OMNIPAQUE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-23 for OMNIPAQUE * manufactured by *.

Event Text Entries

[34995] A 76-yr-old black female to imaging dept for ct of chest, abdomen, and pelvis, with contrast. Contrast medium 240, 50cc bolus given with no reaction; drip continued. 10 mins into procedure pt experienced some sob. Contrast stopped and pt sent to ed where she arrested and expired. Multiple medical problems confirmed by ct, including metastatic ca. Actual cause of death unknown. Body sent to medical examiner. Autopsy results received 10/20/96 which revealed anaphylactic shock.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 62738
• MDR Report Key: 62738
• Date Received: 1996-12-23
• Date of Report: 1996-10-28
• Date of Event: 1996-08-22
• Date Facility Aware: 1996-10-20
• Report Date: 1996-10-28
• Date Reported to FDA: 1996-10-28
• Date Reported to Mfgr: 1996-10-28
• Date Added to Maude: 1997-01-21
• 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
• Reporter Occupation: RISK MANAGER
• 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: OMNIPAQUE
• Generic Name: CT CONTRAST MEDIUM
• Product Code: KTA
• Date Received: 1996-12-23
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: NA
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 62988
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1996-12-23