DRAINAGE BAG WITH REFLUX VALVE DYNC1674 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-02-25 for DRAINAGE BAG WITH REFLUX VALVE DYNC1674 * manufactured by Medline Industries, Inc..

Event Text Entries

[15685659] Reportedly pts contracted urinary tract infections while utilizing the drainbags. The pts were treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1417592-2003-00007
• MDR Report Key: 444679
• Report Source: 07
• Date Received: 2003-02-25
• Date of Report: 2003-02-19
• Date of Event: 2003-01-29
• Date Mfgr Received: 2003-01-29
• Date Added to Maude: 2003-02-27
• 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: ANDREA HAFERKAMP
• Manufacturer Street: ONE MEDLINE PL
• Manufacturer City: MUNDELEIN IL 60060
• Manufacturer Country: US
• Manufacturer Postal: 60060
• Manufacturer Phone: 8478372759
• 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: DRAINAGE BAG WITH REFLUX VALVE
• Generic Name: URINE COLLECTOR
• Product Code: EYZ
• Date Received: 2003-02-25
• Model Number: DYNC1674
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 433657
• Manufacturer: MEDLINE INDUSTRIES, INC.
• Manufacturer Address: ONE MEDLINE PL. MUNDELEIN IL 60060 US
• Baseline Brand Name: DRAINAGE BAG W/REFLUX VALVE
• Baseline Generic Name: URINE COLLECTOR
• Baseline Model No: DYNC1674
• Baseline Device Family: DN11
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2003-02-25