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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pouch, colostomy
Regulation Description Ostomy pouch and accessories.
Product CodeEZQ
Regulation Number 876.5900
Device Class 1


Premarket Reviews
ManufacturerDecision
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 245
Difficult to remove 58
Human-Device Interface Issue 55
Defective item 11
Leak 11
Device operates differently than expected 9
Product quality issue 7
Sticking 7
Material rigid or stiff 5
Failure to Adhere or Bond 5
Device markings issue 5
Increased sensitivity 4
Material disintegration 3
Incomplete or missing packaging 3
Fluid leak 2
Delamination 2
Foreign material present in device 2
Material deformation 2
Packaging issue 2
No code available 2
Failure to expand 2
No Information 1
Malposition of device 1
Misassembled 1
Occlusion within device 1
Loss of or failure to bond 1
Crack 1
Deflation issue 1
Dull 1
Size incorrect for patient 1
Use of Device Issue 1
Defective component 1
Component missing 1
Total Device Problems 454

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 0 0 0 0 0 0
Class III 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Convatec Inc. III Oct-18-2010

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