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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device appliance, facial fracture, external
Product CodeFYI
Regulation Number 878.3250
Device Class 1

MDR Year MDR Reports MDR Events
2022 4 4
2023 9 9
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 6 6
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 2 2
Overheating of Device 2 2
Flare or Flash 1 1
Disconnection 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Atrial Fibrillation 1 1
Unspecified Infection 1 1
Pneumonia 1 1
Numbness 1 1
Loss of consciousness 1 1
Low Oxygen Saturation 1 1

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