OPTIRAY 350 * 1333-16, 1333-21

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-03 for OPTIRAY 350 * 1333-16, 1333-21 manufactured by Mallinckrodt Medical, Inc..

Event Text Entries

[35943] Facility recently changed contrast media.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 54077
• MDR Report Key: 54077
• Date Received: 1996-12-03
• Date of Report: 1996-11-27
• Date of Event: 1996-10-10
• Date Facility Aware: 1996-10-10
• Report Date: 1996-11-27
• Date Added to Maude: 1996-12-10
• 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: BIOMEDICAL ENGINEER
• 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: OPTIRAY 350
• Generic Name: CONTRAST MEDIA
• Product Code: KTA
• Date Received: 1996-12-03
• Model Number: *
• Catalog Number: 1333-16, 1333-21
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 54657
• Manufacturer: MALLINCKRODT MEDICAL, INC.
• Manufacturer Address: 675 MCDONELL BLVD PO BOX 5840 ST LOUIS MO 63134 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1996-12-03