MALLINCKRODT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-29 for MALLINCKRODT * manufactured by Mallinckrodt Medical, Inc..

Event Text Entries

[18334249] Five pts scheduled for ct scans encountered immediate reactions following administration of non-ionic cintrast. The pts' reactions varied from severe nausea to hives, requiring medical attention. The radiologist requested that staff pull the remaining lot and notify the mfr.
Patient Sequence No: 1, Text Type: D, B5

[18210285] Nursing staff member was in the pt's room getting her ready for transfer to the skilled nursing unit. When staff disconnected the diss threaded assembly from the flowmeter, the portion at the neck of the nebulizer completely disconnected the mask from the oxygen source which was set at 95%.
Patient Sequence No: 2, Text Type: D, B5

MAUDE Entry Details

• Report Number: 65788
• MDR Report Key: 65788
• Date Received: 1996-10-29
• Date of Report: 1996-10-29
• Date of Event: 1996-10-22
• Date Facility Aware: 1996-10-23
• Report Date: 1996-10-29
• Date Reported to Mfgr: 1996-10-29
• Date Added to Maude: 1997-02-03
• 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
• 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: OPTIRAY 350 (NON-IONIC CONTRAST)
• Product Code: KTA
• Date Received: 1996-10-29
• Model Number: *
• Catalog Number: *
• Lot Number: T176E
• ID Number: *
• Device Expiration Date: 1998-08-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 65886
• Manufacturer: MALLINCKRODT MEDICAL, INC.
• Manufacturer Address: 675 MCDONNELL BLVD. P.O. BOX 5840 ST LOUIS MO 63134 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1996-10-29
2	0	1. Death	1996-10-29