BARD *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-16 for BARD * manufactured by Bard.

Event Text Entries

[311575] The urologist removed the follower from the urethra and the screw tip of the follower and the filiform remained in the pt. The urologist used a cystoscope to retrieve the filiform segment which was intact upon removal.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1032758
• MDR Report Key: 548285
• Date Received: 2004-07-16
• Date of Report: 2004-07-16
• Date of Event: 2004-07-16
• Date Added to Maude: 2004-10-15
• 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: RISK MANAGER
• 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: BARD
• Generic Name: FILIFORM AND FOLLOWER
• Product Code: FBW
• Date Received: 2004-07-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 537751
• Manufacturer: BARD
• Manufacturer Address: 730 CENTRAL AVE MURRAY HILL NJ 07974 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-07-16