BARD UROLOGICAL CATHETER * 086014

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-09-27 for BARD UROLOGICAL CATHETER * 086014 manufactured by *.

MAUDE Entry Details

• Report Number: 1018233-2002-00029
• MDR Report Key: 419269
• Report Source: 00
• Date Received: 2002-09-27
• Date of Report: 2002-09-27
• Date of Event: 2002-05-29
• Date Mfgr Received: 2002-08-29
• Date Added to Maude: 2002-10-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Manufacturer Contact: VIVIAN STEPHENS, MGR
• Manufacturer Street: 8195 INDUSTRIAL BLVD
• Manufacturer City: COVINGTON GA 30014
• Manufacturer Country: US
• Manufacturer Postal: 30014
• Manufacturer Phone: 7707846902
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BARD UROLOGICAL CATHETER
• Generic Name: UROLOGICAL CATHETER
• Product Code: FEW
• Date Received: 2002-09-27
• Model Number: *
• Catalog Number: 086014
• Lot Number: *
• ID Number: *
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 408315
• Manufacturer: *
• Manufacturer Address: * * *
• Baseline Brand Name: BARDEX MALECOT LATEX DRAIN
• Baseline Generic Name: MALECOT DRAIN
• Baseline Model No: NA
• Baseline Catalog No: 086014
• Baseline ID: NA
• Baseline Device Family: LATEX MALECOT DRAIN
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K910197
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-09-27