UNIVERSAL TRUMPET VALVE ASU1201 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-09 for UNIVERSAL TRUMPET VALVE ASU1201 * manufactured by Cardinal Health, Canada, Inc..

Event Text Entries

[336796] Suction would not release. Had continuous suction from device.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 533644
• MDR Report Key: 533644
• Date Received: 2004-07-09
• Date of Report: 2004-06-14
• Date of Event: 2004-05-04
• Date Facility Aware: 2004-05-04
• Report Date: 2004-06-14
• Date Reported to FDA: 2004-06-15
• Date Added to Maude: 2004-07-13
• 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: 3
• 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: UNIVERSAL TRUMPET VALVE
• Generic Name: *
• Product Code: FEH
• Date Received: 2004-07-09
• Returned To Mfg: 2004-05-04
• Model Number: ASU1201
• Catalog Number: *
• Lot Number: Y3N1784
• ID Number: *
• Device Expiration Date: 2004-06-10
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 522917
• Manufacturer: CARDINAL HEALTH, CANADA, INC.
• Manufacturer Address: 60 INT'L DR TORONTO, ONTARIO CA M9W 6J2

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-07-09