URETHRAL CATHETER 334108

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-03-27 for URETHRAL CATHETER 334108 manufactured by Rusch Inc..

Event Text Entries

[121886] It was reported that the dr had problems sliding some catheters used. Majority of product in the same box worked fine. Only few can not be slid easily during use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2429473-1998-00013
• MDR Report Key: 161090
• Report Source: 05,06
• Date Received: 1998-03-27
• Date of Report: 1998-03-27
• Date Mfgr Received: 1998-03-27
• Date Added to Maude: 1998-04-07
• 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
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: URETHRAL CATHETER
• Generic Name: CONE TIP URETHRAL CATHETER
• Product Code: FGF
• Date Received: 1998-03-27
• Model Number: NA
• Catalog Number: 334108
• Lot Number: 803043
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 156866
• Manufacturer: RUSCH INC.
• Manufacturer Address: 2450 MEADOWBROOK PKWY DULUTH GA 30136 US
• Baseline Brand Name: CONE TIP URETERAL 8FR
• Baseline Generic Name: URETERAL CATHETER
• Baseline Model No: NA
• Baseline Catalog No: 334108
• Baseline ID: NA
• Baseline Device Family: URETERAL CATHETERS
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-03-27