MALECOT CATHETER BARDEX FE6860 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-10 for MALECOT CATHETER BARDEX FE6860 * manufactured by C.r. Bard, Inc..

Event Text Entries

[176901] Catheter tip in bladder. Post op day 1, while attempting to remove catheter, the tip broke off. It was not sutured. Later when touched with forceps, a piece also broke off. Required second surgery to open up wound and remove tip.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 262155
• MDR Report Key: 262155
• Date Received: 2000-02-10
• Date of Report: 1999-12-28
• Date of Event: 1999-10-21
• Report Date: 1999-12-28
• Date Reported to Mfgr: 1999-12-28
• Date Added to Maude: 2000-02-15
• 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: MALECOT CATHETER
• Generic Name: CATHETER
• Product Code: FEW
• Date Received: 2000-02-10
• Model Number: BARDEX FE6860
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 253901
• Manufacturer: C.R. BARD, INC.
• Manufacturer Address: 111 SPRING ST. MURRAY HILL NJ 07974 US
• Baseline Brand Name: MALECOT CATHETER
• Baseline Generic Name: CATHETER
• Baseline Model No: BARDEX FE6860
• Baseline Catalog No: 02 086010
• Baseline ID: FEG

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-02-10