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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device agent, injectable, embolic
Product CodeMFE
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
1 0 0 0 0 1 2 1 1 2 1

Device Problems
No Known Device Problem 177
Migration of device or device component 39
Detachment of device component 22
Entrapment of device or device component 19
Burst 10
No code available 7
Break 6
Leak 6
Difficult to remove 5
Unknown (for use when the device problem is not known) 5
Device operates differently than expected 4
Other (for use when an appropriate device code cannot be identified) 4
Failure to deliver 3
Therapy delivered to incorrect body area 3
Reflux within device 2
User used incorrect product for intended use 2
Burn of device or device component 2
Device or device component damaged by another device 2
Patient-device incompatibility 2
Detachment of device or device component 1
Failure to separate 1
Malposition of device 1
Optical issue 1
Not Applicable 1
No Information 1
Coagulation in device or device ingredient 1
Device remains implanted 1
Device, or device fragments remain in patient 1
Incorrect or inadequate result 1
Material rupture 1
Material separation 1
Sticking 1
Improper or incorrect procedure or method 1
Total Device Problems 334

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