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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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2024
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Device
needle, aspiration and injection, reusable
Product Code
GDM
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
2
2
2021
2
2
2022
3
3
2023
3
3
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
4
4
Break
2
2
Mechanical Problem
1
1
Flaked
1
1
Inadequacy of Device Shape and/or Size
1
1
Mechanical Jam
1
1
Activation Problem
1
1
Material Twisted/Bent
1
1
Difficult to Remove
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
4
4
Fibrosis
2
2
Air Embolism
2
2
No Consequences Or Impact To Patient
2
2
Pneumothorax
2
2
Respiratory Failure
2
2
Bronchospasm
1
1
Septic Shock
1
1
Vomiting
1
1
Cardiac Tamponade
1
1
Sore Throat
1
1
Respiratory Tract Infection
1
1
Needle Stick/Puncture
1
1
Dyspnea
1
1
Fever
1
1
Headache
1
1
Hemoptysis
1
1
Hemorrhage/Bleeding
1
1
Hypoxia
1
1
Unspecified Infection
1
1
Pneumonia
1
1
Cancer
1
1
Syncope/Fainting
1
1
Pericarditis
1
1
Pleural Empyema
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Clinical Signs, Symptoms or Conditions
1
1
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