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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 75
No Known Device Problem 74
Delivered as unsterile product 39
Foreign material present in device 30
Increased sensitivity 25
Unsealed device packaging 25
Improper or incorrect procedure or method 16
Expiration date error 16
Material integrity issue 12
Sticking 11
Device operates differently than expected 11
Difficult to remove 11
Torn material 10
Leak 9
Product quality issue 8
Material fragmentation 8
Device packaging compromised 8
Human-Device Interface Issue 8
Shelf life exceeded 5
Loss of or failure to bond 4
Defective item 4
Buckled material 4
No code available 4
Use of Device Issue 3
Break 3
Material frayed 3
Material disintegration 2
Device abrasion from instrument or another object 2
Difficult to open or remove packaging material 2
Free or unrestricted flow 2
Device handling issue 2
Packaging issue 2
Therapeutic or diagnostic output failure 1
Moisture or humidity problem 1
Manufacturing or shipping issue associated with device 1
Material deformation 1
Material Distortion 1
Split 1
Suction issue 1
Device damaged prior to use 1
Component missing 1
Incomplete or missing packaging 1
Entrapment of device or device component 1
Hole in material 1
Contamination during use 1
Shipping damage or problem 1
Slippage of device or device component 1
Material rupture 1
Material separation 1
Mechanical issue 1
Total Device Problems 456

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

Recalls
Manufacturer Recall Class Date Posted
1 Amd-Ritmed, Inc. II Dec-08-2016

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