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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE 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 Pain (1994); Injury (2348); Disability (2371)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Catalog # unknown as information was not provided but referred to as either gunther tulip mreye, gunther tulip vena cava filter, cook celect vena cava filter, or cook celect platinum. Lot# unknown as information was not provided. Expiration date unknown as lot# is unknown. As catalog# is unknown it could be either k000855, k032426, k061815, k073374, k090140, k112119, k121057 or k121629. Investigation is still in progress.
 
Event Description
Description according to complaint filed: it is alleged that "[pt] received an ivc filter" patient outcome: it is alleged "[pt] suffered permanent and continuous injuries, pain and suffering, disability and impairment. [pt] have suffered emotional trauma, harm and injuries that will continue into the future. [pt] has lost ability to live a normal life, and will continue to be so diminished into the future. " hospital and medical records have been requested but not yet provided.
 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key5366213
MDR Text Key35923455
Report Number3002808486-2016-00015
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
Report Date 03/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2016
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?
Distributor Facility Aware Date01/05/2016
Event Location No Information
Date Manufacturer Received01/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/14/2016 Patient Sequence Number: 1
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