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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 Occlusion Within Device (1423); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Pulmonary Embolism (1498); Hematoma (1884); Pain (1994); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 31/jan/2018 as follows: patient received an implant on (b)(6) 2007 via the left common femoral vein due to deep vein thrombosis. Patient is alleging pain in groin, subdural hematoma, the filter is dislodged, pe and clogged filter.
 
Manufacturer Narrative
(b)(4). Catalog#: unknown but referred to as an ivc filter. Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: it is alleged that "[pt] was implanted with an ivc filter and suffers ongoing injuries. " patient outcome: alleged that [pt] "have 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] have lost their ability to live a normal life, and will continue to be so diminished into the future. Furthermore, [pt] have lost earnings and will continue to lose earnings into the future and have medical bills both past and future related to care because of the ivc filters¿ defects. " hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Catalog#: unknown but referred to as an ivc filter. Expiration date: unknown as lot# is unknown. Explant date unknown as information was not provided. Approx. Age of device: unknown as lot# is unknown. Name and address for importer site: cook medical incorporated (cmi) (b)(4). Pma 510(k): since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. Mfg date: unknown as lot# is unknown. (b)(4). It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation after further information is received and will supplement in accordance with 21 c. F. R. 803. 56 when appropriate.
 
Event Description
Description of event according to initial reporter: it is alleged that "[pt] was implanted with an ivc filter and suffers ongoing injuries. " patient outcome: alleged that [pt] "have 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] have lost their ability to live a normal life, and will continue to be so diminished into the future. Furthermore, [pt] have lost earnings and will continue to lose earnings into the future and have medical bills both past and future related to care because of the ivc filters¿ defects. " 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 4632, IN 47404
8004574500
MDR Report Key6401723
MDR Text Key265238475
Report Number3002808486-2017-00805
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
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 03/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2017
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 Date02/28/2017
Event Location No Information
Date Manufacturer Received02/21/2018
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: 03/14/2017 Patient Sequence Number: 1
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