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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD RECOVERY FILTER

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BARD RECOVERY FILTER Back to Search Results
Device Problem Fracture (1260)
Patient Problem Embolism (1829)
Event Date 12/15/2016
Event Type  Injury  
Event Description
Recovery filter fractured and one arm embolized to right ventricle.
 
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Brand NameRECOVERY
Type of DeviceFILTER
Manufacturer (Section D)
BARD
MDR Report Key6186307
MDR Text Key62861206
Report NumberMW5066788
Device Sequence Number1
Product Code DTK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/15/2016 Patient Sequence Number: 1
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