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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, powered
Regulation Description Powered table.
Product CodeINQ
Regulation Number 890.3760
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 3 3
2023 1 1
2024 1 1
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Remains Activated 2 2
Entrapment of Device 2 2
Unintended Movement 2 2
Thermal Decomposition of Device 2 2
Device Emits Odor 2 2
Patient-Device Incompatibility 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Electrical Shorting 1 1
Unintended System Motion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 2 2
Unspecified Tissue Injury 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Vertigo 1 1
Discomfort 1 1
Insufficient Information 1 1
Pain 1 1
Partial thickness (Second Degree) Burn 1 1
Vertebral Fracture 1 1

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