RUSCH CONDOM CATHETER - 3/4" E7000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-01-15 for RUSCH CONDOM CATHETER - 3/4" E7000 manufactured by Rusch, Inc., Decatur.

Event Text Entries

[19155128] Customer reports that catheter leaks within 8-9 hours from attachment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1045162-2002-00273
• MDR Report Key: 438888
• Report Source: 04
• Date Received: 2003-01-15
• Date of Report: 2003-01-15
• Date Mfgr Received: 2002-12-18
• Date Added to Maude: 2003-01-24
• 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: NICOLE BLACKMAN
• Manufacturer Street: 2450 MEADOWBROOK PARKWAY
• Manufacturer City: DULUTH GA 30136
• Manufacturer Country: US
• Manufacturer Postal: 30136
• Manufacturer Phone: 7706230816
• 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: RUSCH CONDOM CATHETER - 3/4"
• Generic Name: URINARY CATHETERIZATION SYSTEM
• Product Code: EXJ
• Date Received: 2003-01-15
• Model Number: NA
• Catalog Number: E7000
• Lot Number: 118851
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 427811
• Manufacturer: RUSCH, INC., DECATUR
• Manufacturer Address: 5335 DIVIDEND DR. DECATUR GA 30035 US
• Baseline Brand Name: MMG
• Baseline Generic Name: COMDOM CATHETER
• Baseline Model No: NA
• Baseline Catalog No: E7000
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-01-15