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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cover, cast
Product CodeKIA
Regulation Number 880.6185
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2016 1 1
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Moisture or Humidity Problem 2 2
Patient-Device Incompatibility 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Itching Sensation 1 1
Skin Irritation 1 1
No Consequences Or Impact To Patient 1 1
Urticaria 1 1
No Code Available 1 1

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