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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dressing,wound,hydrophilic
Regulation Description Hydrophilic wound dressing.
Product CodeNAC
Regulation Number 878.4018
Device Class 1


Premarket Reviews
ManufacturerDecision
SCIVOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to Adhere or Bond 73
No Known Device Problem 71
Delivered as unsterile product 29
Foreign material present in device 27
Increased sensitivity 25
Unsealed device packaging 24
Expiration date error 16
Improper or incorrect procedure or method 16
Device operates differently than expected 11
Difficult to remove 10
Sticking 10
Leak 9
Product quality issue 8
Device packaging compromised 8
Human-Device Interface Issue 8
Shelf life exceeded 5
Material fragmentation 5
Loss of or failure to bond 4
Buckled material 4
Material frayed 3
Material integrity issue 3
Free or unrestricted flow 2
Packaging issue 2
Torn material 2
No code available 2
Material disintegration 2
Use of Device Issue 2
Defective item 2
Difficult to open or remove packaging material 2
Device abrasion from instrument or another object 2
Split 1
Suction issue 1
Component missing 1
Incomplete or missing packaging 1
Manufacturing or shipping issue associated with device 1
Material deformation 1
Material Distortion 1
Slippage of device or device component 1
Material separation 1
Entrapment of device or device component 1
Contamination during use 1
Hole in material 1
Mechanical issue 1
Therapeutic or diagnostic output failure 1
Moisture or humidity problem 1
Total Device Problems 402

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 0 0 0 0 0 0 0


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