URETERAL DRAINAGE BAG 7000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2002-10-30 for URETERAL DRAINAGE BAG 7000 manufactured by Portex, Inc..

Event Text Entries

[267698] The user alleges that they had one patient that had a latex reaction to the ureteral drainage bag. The patient developed a rash.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1217052-2002-00033
• MDR Report Key: 425109
• Report Source: 06,07
• Date Received: 2002-10-30
• Date of Report: 2002-09-30
• Date Mfgr Received: 2002-09-30
• Date Added to Maude: 2002-11-01
• 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: BRIAN FARIAS
• Manufacturer Street: 10 BOWMAN DRIVE
• Manufacturer City: KEENE NH 03431
• Manufacturer Country: US
• Manufacturer Postal: 03431
• Manufacturer Phone: 6033523812
• 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: URETERAL DRAINAGE BAG
• Generic Name: URETERAL DRAINAGE BAG
• Product Code: EXG
• Date Received: 2002-10-30
• Model Number: NA
• Catalog Number: 7000
• Lot Number: UNK
• 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: 414164
• Manufacturer: PORTEX, INC.
• Manufacturer Address: 10 BOWMAN DR. KEENE NH 03431 US
• Baseline Brand Name: URETERAL DRAINAGE BAG
• Baseline Generic Name: OSTOMY POUCH & ACCESSORIES
• Baseline Model No: NA
• Baseline Catalog No: 7000
• Baseline ID: NA
• Baseline Device Family: NA
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: *
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-10-30