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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD MEDICAL BARD ECLIPSE VENA CAVA FILTER-FEMORAL

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BARD MEDICAL BARD ECLIPSE VENA CAVA FILTER-FEMORAL Back to Search Results
Model Number EC500F
Event Date 09/29/2012
Event Type  Malfunction  
Event Description

A bard eclipse vena cava filter was placed (b)(6) 2012. Placement was uneventful. On (b)(6) 2012, an abdominal x-ray showed that the filter rotated 90 degrees, and is now in a horizontal position. A second filter was placed above the current filter.

 
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Brand NameBARD ECLIPSE VENA CAVA FILTER-FEMORAL
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD MEDICAL
UT
MDR Report Key2781168
Report NumberMW5027176
Device Sequence Number1
Product CodeDTK
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/03/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEC500F
Device LOT NumberGFWC1092
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 10/03/2012 Patient Sequence Number: 1
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