MALLINCKRODT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-04 for MALLINCKRODT * manufactured by Mallinckrodt Med., Inc..

Event Text Entries

[47142] Anaphylactic shock reaction after receiving ivp contrast. Pt expired.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 74826
• MDR Report Key: 74826
• Date Received: 1997-03-04
• Date of Report: 1997-03-03
• Date of Event: 1997-02-27
• Date Facility Aware: 1997-02-27
• Report Date: 1997-03-03
• Date Reported to FDA: 1997-03-03
• Date Reported to Mfgr: 1997-03-03
• Date Added to Maude: 1997-03-11
• 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: RADIOLOGIC TECHNOLOGIST
• 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: MALLINCKRODT
• Generic Name: CONRAY 43
• Product Code: KTA
• Date Received: 1997-03-04
• Model Number: *
• Catalog Number: *
• Lot Number: T155E, EXPIRE 7/99
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 74622
• Manufacturer: MALLINCKRODT MED., INC.
• Manufacturer Address: 675 MCDONNELL BLVD PO BOX 5840 ST LOUIS MO 63134 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1997-03-04