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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL INC COOK CELECT VENA CAVA FILTER

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COOK MEDICAL INC COOK CELECT VENA CAVA FILTER Back to Search Results
Model Number REF# IGTCFS-65-1-FEM-CELECT
Device Problem Malfunction
Event Date 09/30/2013
Event Type  Malfunction  
Event Description

Pt was getting an ivc filter placed by trauma. Upon deployment of the filter, one of the legs bent. Md progress notes states he will consider having the pt will need to go to ir to have defective filter removed and a new filter placed. The filter is a cook celect vena cava filter ref igtcfs-65-1-fem celect. Order number (b)(4).

 
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Brand NameCOOK CELECT VENA CAVA FILTER
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
COOK MEDICAL INC
bloomington
MDR Report Key3546130
Report Number3546130
Device Sequence Number1
Product CodeDTK
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/30/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREF# IGTCFS-65-1-FEM-CELECT
Device Catalogue NumberG52914
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/30/2013
Event Location Hospital
Date Report TO Manufacturer09/30/2013
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 11/07/2013 Patient Sequence Number: 1
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