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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dressing,wound,occlusive
Regulation Description Occlusive wound dressing.
Product CodeNAD
Regulation Number 878.4020
Device Class 1


Premarket Reviews
ManufacturerDecision
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ENZYSURGE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 89
Foreign material present in device 73
Failure to Adhere or Bond 70
Delivered as unsterile product 45
Unsealed device packaging 43
Device operates differently than expected 22
Difficult to remove 14
No code available 14
No Information 11
Packaging issue 8
Device packaging compromised 8
Sticking 7
Unknown (for use when the device problem is not known) 7
Human-Device Interface Issue 5
Material integrity issue 5
Defective item 4
Material separation 4
Device expiration issue 4
Material fragmentation 4
Tear, rip or hole in device packaging 3
Inadequate user interface 3
Difficult to open or remove packaging material 3
Patient-device incompatibility 3
Material deformation 3
Product quality issue 2
Material twisted 2
Failure to obtain samples 2
Device, removal of (non-implant) 2
Material frayed 2
Loss of or failure to bond 2
Material disintegration 2
Melted 2
User used incorrect product for intended use 1
Shelf life exceeded 1
Shipping damage or problem 1
Material rigid or stiff 1
Material discolored 1
Disconnection 1
Leak 1
Wrinkled 1
Increased sensitivity 1
Device damaged prior to use 1
Use of Device Issue 1
Device disinfection or sterilization issue 1
Item contaminated during manufacturing or shipping 1
Total Device Problems 481

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

Recalls
Manufacturer Recall Class Date Posted
1 Aplicare, Inc. III Apr-08-2010
2 Coloplast Manufacturing US, LLC III Oct-24-2014
3 Covidien LLC II Mar-27-2017

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