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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device collector, ostomy
Regulation Description Ostomy pouch and accessories.
Product CodeEXB
Regulation Number 876.5900
Device Class 1


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 6
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 11
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 14
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 5
PFIZER
  SUBSTANTIALLY EQUIVALENT 2
VANCE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 12
No Known Device Problem 11
Human-Device Interface Issue 10
Device operates differently than expected 3
Leak 2
Occlusion within device 1
Material deformation 1
No flow 1
Total Device Problems 41

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

Recalls
Manufacturer Recall Class Date Posted
1 Coloplast Manufacturing US, LLC II Sep-09-2011
2 ConvaTec III Jul-02-2008
3 ConvaTec III May-07-2008
4 Convatec Inc. III Oct-05-2011
5 Convatec Inc. III Mar-08-2011

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