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U.S. Department of Health and Human Services

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

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COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
William cook (b)(4) initially reported event under mfr report # 3002808486-2016-00325. New information was received identifying that the product was a cook inc. Manufactured device. An updated emdr report was submitted under cook inc. Mfr report # 1820334-2016-00677, follow up # 1. This was in reference to william cook (b)(4) mfr report # 3002808486-2016-00325. However, the initial for mfr report # 1820334-2016-00677 had already been used on a different complaint. Cook is now submitting an initial report under mfr report #1820334-2016-01610 to correct this issue. Blank fields on this form indicate the information is unknown, unavailable or unchanged. (b)(4). Evaluation- 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 injuries. No notes of relevance on found in the work order, nor on filter lots. No other complaints received under the same lot. There is no evidence to suggest the device was not manufactured to specifications. We have notified appropriate personnel and will continue to monitor for similar events. If additional information is received, the report will be re-opened for further investigation.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2012 at (b)(6) in (b)(6). " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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Brand NameGUNTHER TULIP JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
rita harden
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6175205
MDR Text Key62418545
Report Number1820334-2016-01610
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Attorney
Type of Report Initial
Report Date 05/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberIGTCFS-65-JUG
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 Received07/06/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/01/2011
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: 12/15/2016 Patient Sequence Number: 1
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