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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 72
No Known Device Problem 71
Increased sensitivity 25
Delivered as unsterile product 24
Foreign material present in device 24
Unsealed device packaging 24
Expiration date error 16
Improper or incorrect procedure or method 14
Device operates differently than expected 11
Difficult to remove 10
Sticking 10
Leak 9
Device packaging compromised 8
Human-Device Interface Issue 8
Product quality issue 6
Material fragmentation 5
Shelf life exceeded 5
Loss of or failure to bond 4
Buckled material 4
Material frayed 3
Material integrity issue 3
Material disintegration 2
No code available 2
Device abrasion from instrument or another object 2
Use of Device Issue 2
Defective item 2
Difficult to open or remove packaging material 2
Packaging issue 2
Torn material 2
Free or unrestricted flow 2
Manufacturing or shipping issue associated with device 1
Material Distortion 1
Moisture or humidity problem 1
Entrapment of device or device component 1
Slippage of device or device component 1
Split 1
Mechanical issue 1
Hole in material 1
Material separation 1
Incomplete or missing packaging 1
Material deformation 1
Suction issue 1
Component missing 1
Therapeutic or diagnostic output failure 1
Contamination during use 1
Total Device Problems 389

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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