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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device source, carrier, fiberoptic light
Product CodeEQH
Regulation Number 874.4350
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2016 2 2
2017 3 3
2019 1 1
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Smoking 3 3
Break 2 2
Excessive Heating 2 2
Thermal Decomposition of Device 1 1
Detachment Of Device Component 1 1
Loose or Intermittent Connection 1 1
Device Emits Odor 1 1
Device Operates Differently Than Expected 1 1
Human-Device Interface Problem 1 1
Optical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Consequences Or Impact To Patient 2 2
Superficial (First Degree) Burn 1 1
Foreign Body In Patient 1 1
Partial thickness (Second Degree) Burn 1 1
Burn(s) 1 1

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