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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device crutch
Regulation Description Crutch.
Product CodeIPR
Regulation Number 890.3150
Device Class 1

Device Problems
Break 15
Component(s), broken 10
Fracture 9
Detachment of device component 5
Shaft break 3
Bent 2
Product quality issue 2
Component(s), worn 2
Disassembly 2
Defective item 2
Device operates differently than expected 2
No Known Device Problem 2
Material deformation 1
Material integrity issue 1
Unable to confirm conditions of use 1
Detachment of device or device component 1
Handrest detachment 1
Hole in material 1
Device maintenance issue 1
Collapse 1
Slippage of device or device component 1
Unstable 1
Unknown (for use when the device problem is not known) 1
Defective component 1
Out-of-box failure 1
Device Issue 1
Total Device Problems 70

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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