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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
Regulation Description Ear, nose, and throat fiberoptic light source and carrier.
Product CodeEQH
Regulation Number 874.4350
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2024 2 2
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Excessive Heating 2 2
Material Puncture/Hole 1 1
Thermal Decomposition of Device 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Burn(s) 1 1
Partial thickness (Second Degree) Burn 1 1

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