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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
2015 14 14
2017 4 4
2018 4 4
2019 1 1
2020 1 1
2021 2 2
2022 4 4
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 14 14
Patient-Device Incompatibility 14 14
Improper or Incorrect Procedure or Method 12 12
Product Quality Problem 3 3
Appropriate Term/Code Not Available 3 3
Decrease in Pressure 3 3
Device Slipped 3 3
Detachment of Device or Device Component 3 3
Mechanical Problem 2 2
Detachment Of Device Component 2 2
Failure To Adhere Or Bond 2 2
Device Dislodged or Dislocated 1 1
Difficult to Open or Close 1 1
Unintended Movement 1 1
Defective Device 1 1
Break 1 1
Insufficient Information 1 1
Noise, Audible 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 15 15
Hemorrhage/Bleeding 7 7
No Clinical Signs, Symptoms or Conditions 4 4
Blood Loss 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Foreign Body Reaction 1 1
Unspecified Infection 1 1
Seizures 1 1
No Code Available 1 1
Insufficient Information 1 1

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