RETROGUARD 4007200 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-04-16 for RETROGUARD 4007200 * manufactured by Quest Medical, Inc..

Event Text Entries

[265622] The value was returned from the kit packer's customer because the customer could not establish flow through the valve. There appeared to be no slit in the duckbill.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1649914-2003-00013
• MDR Report Key: 454913
• Report Source: 05,06
• Date Received: 2003-04-16
• Date of Report: 2003-04-16
• Date Mfgr Received: 2003-02-27
• Date Added to Maude: 2003-04-23
• 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
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: KATHRYN THOMPSON
• Manufacturer Street: ONE ALLENTOWN PKWY
• Manufacturer City: ALLEN TX 75002
• Manufacturer Country: US
• Manufacturer Postal: 75002
• Manufacturer Phone: 9723909800
• 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: RETROGUARD
• Generic Name: FLOW CHECK VALVE
• Product Code: MJJ
• Date Received: 2003-04-16
• Model Number: 4007200
• Catalog Number: *
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 443910
• Manufacturer: QUEST MEDICAL, INC.
• Manufacturer Address: ONE ALLENTOWN PKWY. ALLEN TX 75002 US
• Baseline Brand Name: RETROGUARD
• Baseline Generic Name: FLOW CHECK VALVE
• Baseline Model No: 4007200
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-04-16