D-STAT FLOWABLE HEMOSTAT 4000 *

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 2006-02-27 for D-STAT FLOWABLE HEMOSTAT 4000 * manufactured by Vascular Solutions, Inc..

Event Text Entries

[452528] The physician used d-stat flowable in a liver biopsy procedure. The physician stated that the patient reported experiencing pain during d-stat flowable delivery. No further complications were reported by the physician.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2134812-2006-00005
• MDR Report Key: 679701
• Report Source: 06,07
• Date Received: 2006-02-27
• Date of Report: 2006-02-15
• Date of Event: 2006-02-15
• Date Mfgr Received: 2006-02-15
• Date Added to Maude: 2006-03-01
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: JULIE TAPPER
• Manufacturer Street: 6464 SYCAMORE CT.
• Manufacturer City: MINNEAPOLIS MN 55369
• Manufacturer Country: US
• Manufacturer Postal: 55369
• Manufacturer Phone: *
• 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: D-STAT FLOWABLE HEMOSTAT
• Generic Name: TOPICAL HEMOSTAT
• Product Code: MHW
• Date Received: 2006-02-27
• Model Number: 4000
• Catalog Number: *
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 668971
• Manufacturer: VASCULAR SOLUTIONS, INC.
• Manufacturer Address: * MINNEAPOLIS MN 55369 US
• Baseline Brand Name: D-STAT FLOWABLE HEMOSTAT
• Baseline Generic Name: TOPICAL HEMOSTAT
• Baseline Model No: 4000
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: NA
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: 12
• Baseline PMA Flag: Y
• Premarket Approval: P9900
• Baseline 510K PMN: Y
• Premarket Notification: K012293
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2006-02-27