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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
2010
2011
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2014
2015
2016
2017
2018
2019
2020
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2024
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Device
cable
Product Code
ISN
Regulation Number
890.3420
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
7
7
2015
19
19
2016
2
2
2017
4
4
2018
6
6
2019
7
7
2020
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
16
16
Device Packaging Compromised
7
7
Delivered as Unsterile Product
6
6
Incorrect, Inadequate or Imprecise Result or Readings
6
6
Component Missing
6
6
Nonstandard Device
5
5
Unsealed Device Packaging
5
5
Device Operates Differently Than Expected
4
4
Packaging Problem
3
3
Positioning Problem
2
2
Temperature Problem
2
2
Material Integrity Problem
2
2
Energy Output Problem
2
2
Material Fragmentation
2
2
Device Contamination with Body Fluid
1
1
High Readings
1
1
Device Displays Incorrect Message
1
1
Contamination /Decontamination Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
22
22
No Patient Involvement
17
17
No Consequences Or Impact To Patient
7
7
Pain
2
2
Eye Injury
2
2
Muscle Spasm(s)
1
1
Device Embedded In Tissue or Plaque
1
1
No Code Available
1
1
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