VIRDEN RECTAL CATHETER 263530

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-05-13 for VIRDEN RECTAL CATHETER 263530 manufactured by Rusch Sdn. Bhd..

Event Text Entries

[15685058] Customer reports balloon would not deflate.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8040412-2003-00052
• MDR Report Key: 460765
• Report Source: 06
• Date Received: 2003-05-13
• Date of Report: 2003-05-09
• Date Mfgr Received: 2003-05-01
• Date Added to Maude: 2003-05-21
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: ROLANDA SCOTT, COORDINATOR
• Manufacturer Street: 2450 MEADOWBROOK PARKWAY
• Manufacturer City: DULUTH GA 30096
• Manufacturer Country: US
• Manufacturer Postal: 30096
• 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: VIRDEN RECTAL CATHETER
• Generic Name: UROLOGICAL
• Product Code: GBT
• Date Received: 2003-05-13
• Model Number: NA
• Catalog Number: 263530
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 449707
• Manufacturer: RUSCH SDN. BHD.
• Manufacturer Address: P.O. BOX 28, KAMUNTING INDUSTRIAL ESTATE PERAK MY 3460
• Baseline Brand Name: VIRDEN RECTAL CATHETER
• Baseline Generic Name: UROLOGICAL
• Baseline Model No: NA
• Baseline Catalog No: 263530
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-05-13