URETERAL CATHETERS 334108

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-10-22 for URETERAL CATHETERS 334108 manufactured by Rusch, Inc..

Event Text Entries

[82979] When the catheter was being removed, the cone tip became dislodged from the shaft and remained in the patient. The tip had to be retrieved.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2429473-1998-00065
• MDR Report Key: 193646
• Report Source: 05
• Date Received: 1998-10-22
• Date of Report: 1998-10-22
• Date of Event: 1998-10-21
• Date Added to Maude: 1998-10-28
• 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: URETERAL CATHETERS
• Generic Name: CONE TIP URETERAL CATHETER
• Product Code: FGF
• Date Received: 1998-10-22
• Model Number: NA
• Catalog Number: 334108
• Lot Number: 83312
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 188139
• Manufacturer: RUSCH, INC.
• Manufacturer Address: 2450 MEADOWBROOK PKWY. DULUTH GA 30096 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. Required No Informationntervention	1998-10-22