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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-UNI-CELECT-PERM
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Pulmonary Embolism (1498); Myocardial Infarction (1969); Perforation of Vessels (2135); No Information (3190)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Blank fields on this form indicate the information is unknown or unavailable. Catalog# is unknown but referred to as cook celect filter. Occupation: non-healthcare professional. 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 if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.

 
Event Description

'it is alleged that "[pt] received a cook celect filter on (b)(6) 2009". 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 NameCOOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER
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 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key9085523
MDR Text Key159130426
Report Number3002808486-2019-01502
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/24/2011
Device Catalogue NumberIGTCFS-65-UNI-CELECT-PERM
Device LOT NumberE2326041
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 Received10/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/24/2009
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: 09/19/2019 Patient Sequence Number: 1
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