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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Nausea (1970); Perforation of Vessels (2135); Vomiting (2144); No Information (3190)
Event Type  Injury  
Event Description

It is alleged that the patient received a cook celect filter on (b)(6) 2012. The patient alleges to have been injured without further explanation.

 
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Brand NameCOOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
MDR Report Key8860894
MDR Text Key153284323
Report Number3005580113-2019-00156
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 Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/17/2014
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT
Device LOT NumberE2834053
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/24/2019
Distributor Facility Aware Date09/11/2019
Event Location Other
Date Report TO Manufacturer08/30/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/01/2011
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: 08/05/2019 Patient Sequence Number: 1
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