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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device adaptor, hygiene
Regulation Description Daily activity assist device.
Product CodeILS
Regulation Number 890.5050
Device Class 1

Device Problems
Break 121
Crack 72
Unstable 72
Bent 47
Product quality issue 33
Collapse 16
Detachment of device component 14
Buckled material 11
Out-of-box failure 10
Unraveled material 8
Mechanical jam 7
No Known Device Problem 6
Torn material 5
Device operates differently than expected 5
Connection issue 4
Leak 4
Device inoperable 3
Material separation 2
Device damaged prior to use 2
Component falling 2
Bolus mechanism failure 2
Fracture 2
Material integrity issue 2
Tipover 2
Unintended movement 2
No Information 1
Unable to confirm conditions of use 1
Deployment issue 1
Detachment of device or device component 1
Tube(s), buckling of 1
Failure to align 1
Split 1
Material frayed 1
Component(s), worn 1
Defective component 1
Bacterial contamination of device 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Sticking 1
Total Device Problems 468

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 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Etac Supply Center Ab II Aug-13-2015
2 Etac Supply Center Ab II Jul-15-2015

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