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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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2020
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2024
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Device
scalpel, one-piece
Product Code
GDX
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
6
6
2020
8
8
2021
21
21
2022
5
5
2023
5
5
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
7
7
Difficult to Open or Remove Packaging Material
7
7
Tear, Rip or Hole in Device Packaging
6
6
Unintended Movement
4
4
Detachment of Device or Device Component
3
3
Material Integrity Problem
3
3
Break
3
3
Unsealed Device Packaging
3
3
Pitted
3
3
Degraded
2
2
Device Contaminated During Manufacture or Shipping
2
2
Mechanical Jam
1
1
Dull, Blunt
1
1
Contamination /Decontamination Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Material Erosion
1
1
Delivered as Unsterile Product
1
1
Product Quality Problem
1
1
Retraction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
31
31
No Known Impact Or Consequence To Patient
6
6
Laceration(s)
3
3
No Consequences Or Impact To Patient
3
3
Hemorrhage/Bleeding
1
1
Necrosis
1
1
No Code Available
1
1
Insufficient Information
1
1
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