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 Number2134812-2006-00005
MDR Report Key679701
Report Source06,07
Date Received2006-02-27
Date of Report2006-02-15
Date of Event2006-02-15
Date Mfgr Received2006-02-15
Date Added to Maude2006-03-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactJULIE TAPPER
Manufacturer Street6464 SYCAMORE CT.
Manufacturer CityMINNEAPOLIS MN 55369
Manufacturer CountryUS
Manufacturer Postal55369
Manufacturer Phone*
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameD-STAT FLOWABLE HEMOSTAT
Generic NameTOPICAL HEMOSTAT
Product CodeMHW
Date Received2006-02-27
Model Number4000
Catalog Number*
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key668971
ManufacturerVASCULAR SOLUTIONS, INC.
Manufacturer Address* MINNEAPOLIS MN 55369 US
Baseline Brand NameD-STAT FLOWABLE HEMOSTAT
Baseline Generic NameTOPICAL HEMOSTAT
Baseline Model No4000
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyNA
Baseline Shelf Life Contained*
Baseline Shelf Life [Months]12
Baseline PMA FlagY
Premarket ApprovalP9900
Baseline 510K PMNY
Premarket NotificationK012293
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2006-02-27

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