BLAKEMORE TUBE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-08 for BLAKEMORE TUBE * manufactured by Bard.

Event Text Entries

[345870] Prior to inserting a blakemore tube into a pt, control bleeding from esophagel varices, the staff noted that the tube was defective; tear was noted around the neck of the balloon.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034871
• MDR Report Key: 580579
• Date Received: 2005-03-08
• Date of Report: 2005-03-08
• Date of Event: 2005-02-28
• Date Added to Maude: 2005-03-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BLAKEMORE TUBE
• Generic Name: BLAKEMORE TUBE
• Product Code: FEF
• Date Received: 2005-03-08
• Model Number: *
• Catalog Number: *
• Lot Number: 39JM002
• ID Number: *
• Device Expiration Date: 2005-10-31
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 570426
• Manufacturer: BARD
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-03-08