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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cable
Regulation Description External limb prosthetic component.
Product CodeISN
Regulation Number 890.3420
Device Class 1

Device Problems
Incorrect or inadequate result 38
Device packaging compromised 7
Component missing 6
Unsealed device packaging 5
Nonstandard device or device component 5
Device operates differently than expected 4
Packaging issue 3
Device damaged prior to use 2
Positioning Issue 2
Material integrity issue 2
Device stops intermittently 1
Device inoperable 1
Device contamination with blood or blood product 1
Device displays error message 1
Disinfection or Sterilization Issue at User Location 1
Unable to obtain readings 1
Break 1
Material fragmentation 1
Normal 1
Total Device Problems 83

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