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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Death (1802); Pain (1994); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2015
Event Type  Death  
Manufacturer Narrative
Investigation: no information regarding the event has been provided. We have investigated based on the information received to date, and are closing the report until further information is received for investigation. Impossible to comment on alleged injury. If additional information is received, the report will be re-opened for further investigation.
 
Event Description
It is alleged the patient received a cook gunther tulip on (b)(6) 2008 (b)(6). It is alleged that patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
Unknown if the following patient and device codes are listed in the ifu. (b)(4). Corrected data based on new information received: serious injury to death. The patient involved was reported to be deceased without further details, therefore this report is being submitted as ¿death¿ related as a cautionary measure. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 06/10/2016 as follows: plaintiff allegedly received an implant on (b)(6)2008 via the right femoral vein due to dvt in right lower leg. Plaintiff is alleging death, bleeding, and leg pain. The patient involved was reported to be deceased without further details, with the date of death reported as (b)(6)2015.
 
Manufacturer Narrative
Additional information: the patient involved was reported to be deceased without further details, therefore this report is being submitted as ¿death¿ related as a cautionary measure. Investigation is reopened due to additional information provided. It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'tulip, death, bleeding, leg pain (assumed to be a pe)'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
Plaintiff alleges "autopsy revealed clogged filter, fresh blood around filter".
 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key5520695
MDR Text Key40990252
Report Number1820334-2016-00171
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 07/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/02/2016
Event Location Hospital
Date Manufacturer Received07/18/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/23/2016 Patient Sequence Number: 1
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