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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
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
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
MDR Text Key3038451
Report NumberMW5027176
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
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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