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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
device, occlusion, umbilical
Product Code
FOD
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
2024
3
3
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
Appropriate Term/Code Not Available
3
3
Device Slipped
3
3
Decrease in Pressure
3
3
Product Quality Problem
3
3
Detachment of Device or Device Component
3
3
Difficult to Open or Close
3
3
Device Dislodged or Dislocated
2
2
Failure To Adhere Or Bond
2
2
Mechanical Problem
2
2
Detachment Of Device Component
2
2
Positioning Failure
1
1
Unintended Movement
1
1
Insufficient Information
1
1
Defective Device
1
1
Break
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
8
8
No Clinical Signs, Symptoms or Conditions
6
6
Blood Loss
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Unspecified Infection
1
1
Seizures
1
1
No Code Available
1
1
Foreign Body Reaction
1
1
Insufficient Information
1
1
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