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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC.BARD IVC FILTERG2 IVC FILTER

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BARD PERIPHERAL VASCULAR INC. BARD IVC FILTER G2 IVC FILTER   Back to Search Results
Device Problem Break
Event Date 08/25/2011
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

Ivc implanted at outside hospital (b)(6) 2008. Fracture of ivc arm found on ct. Device removed during hospitalization on (b)(6) 2011.

 
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Brand NameBARD IVC FILTER
Type of DeviceG2 IVC FILTER
Manufacturer (Section F)
BARD PERIPHERAL VASCULAR INC.
po box 1740
1625 west 3rd
st. tempe AZ 85280 1740
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR INC.
po box 1740
1625 west 3rd
st. tempe AZ 85280 1740
Device Event Key2284601
MDR Report Key2263720
Event Key2160616
Report Number2263720
Device Sequence Number1
Product CodeDTK
Report Source User Facility
Source Type Unknown
Reporter Occupation Other
Type of Report Initial
Report Date 09/19/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/19/2011
Distributor Facility Aware Date07/06/2011
Device Age4 yr
Event Location Home
Date Report TO Manufacturer09/19/2011
Was Device Evaluated By Manufacturer? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

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