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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); Patient Problem/Medical Problem (2688); No Code Available (3191)
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. This report is required by the fda under 21 cfr part 803. This report is based on unconfirmed information submitted by others. Neither the.
 
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 Key5366212
MDR Text Key35968728
Report Number3002808486-2016-00018
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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