OPTIRAY 320 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-08 for OPTIRAY 320 * manufactured by Mallinckrodt Medical,inc..

Event Text Entries

[25083] Pt experienced cardiac arrest. Approx 2 1/2 hours after ct of chest.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 46661
• MDR Report Key: 46661
• Date Received: 1996-08-08
• Date of Report: 1996-08-07
• Date Added to Maude: 1996-11-07
• 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 Sequence Number: 1

• Brand Name: OPTIRAY 320
• Generic Name: LOVERSOL INJECTION 68%
• Product Code: KTA
• Date Received: 1996-08-08
• Model Number: *
• Catalog Number: *
• Lot Number: T003H
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 47480
• Manufacturer: MALLINCKRODT MEDICAL,INC.
• Manufacturer Address: 675 MCDONNELL BLVD PO BOX 5840 ST LOUIS MO 63134 US

Device Sequence Number: 2

• Brand Name: BURRON DISCOFIX
• Generic Name: 4-WAY STOPCOCK
• Product Code: FMG
• Date Received: 1996-08-08
• Model Number: D500
• Catalog Number: H8021-456020
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 47485
• Manufacturer: BURRON MEDICAL, INC.
• Manufacturer Address: 824 12TH AVE BETHLEHEM PA 180183524 US

Device Sequence Number: 3

• Brand Name: LOERLOK
• Generic Name: DISPOSABLE SYRINGE
• Product Code: FMF
• Date Received: 1996-08-08
• Model Number: *
• Catalog Number: 309663, 60CC
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 47488
• Manufacturer: BECTON DICKINSON
• Manufacturer Address: 1 BECTON DR FRANKLIN LAKES NJ 074171884 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1996-08-08