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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Disability (2371)
Event Type  malfunction  
Manufacturer Narrative
This report is a duplicate of the report submitted with medwatch report on 10nov2017. The report was incorrectly submitted as follow up #2. No additional information was provided or further investigation was conducted.
 
Event Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
 
Manufacturer Narrative
Cook inc previously submitted follow up 1 incorrectly. Cook inc. Is submitting thir follow up as a correction.
 
Manufacturer Narrative
Manufacturer pr# (b)(4). William cook europe initially reported event under mfr report # 3002808486-2016-01412. New information was received identifying that the product was a cook inc. Manufactured device. (b)(4). The event is currently under investigation; a supplemental report will be submitted upon completion.
 
Event Description
It is alleged that "[pt] received a gunther tulip filter on (b)(6) 2012. It is alleged that the filter is unable to be retrieved without further details provided. It was reported that the patient is experiencing pain, suffering and disability.
 
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Brand NameGUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6405575
MDR Text Key251033252
Report Number1820334-2017-00569
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberIGTCFS-65-FEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/01/2011
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: 03/15/2017 Patient Sequence Number: 1
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