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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, occlusion, umbilical
Product CodeFOD
Regulation Number 880.5950
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 2 2
2022 4 4
2023 4 4
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 3 3
Product Quality Problem 3 3
Detachment of Device or Device Component 3 3
Decrease in Pressure 3 3
Mechanical Problem 2 2
Device Dislodged or Dislocated 2 2
Positioning Failure 1 1
Defective Device 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Noise, Audible 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Hemorrhage/Bleeding 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Blood Loss 1 1
Insufficient Information 1 1

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