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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-UNI-CELECT
Device Problems Structural Problem (2506); Device Tipped Over (2589); Insufficient Information (3190)
Patient Problems Pain (1994); Perforation of Vessels (2135); Discomfort (2330); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Manufacturer ref# (b)(4). Catalog# is unknown but referred to as cook celect filter. Occupation: non-healthcare professional.
 
Event Description
Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2012. It is alleged that the [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided. ".
 
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Brand NameCOOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
lissi walmann
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key11357176
MDR Text Key242066798
Report Number3002808486-2021-00140
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/22/2015
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT
Device Lot NumberE2921261
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 Received05/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2012
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: 02/22/2021 Patient Sequence Number: 1
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