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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dressing, wound and burn, interactive
Product CodeMGR
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
1 5 6 7 9 9 8 1 0 3 4

Device Problems
No Known Device Problem 7
Bacterial contamination of device 2
Failure to Adhere or Bond 2
Device expiration issue 1
Improper or incorrect procedure or method 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Device operates differently than expected 1
Manufacturing or shipping issue associated with device 1
Total Device Problems 17

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 1 1 2 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Organogenesis, Inc. II Mar-23-2011
2 Organogenesis, Inc. II Mar-23-2011
3 Organogenesis, Inc. II Sep-28-2010
4 Organogenesis, Inc. II Nov-12-2009
5 Organogenesis, Inc. II Jan-24-2008

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