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TPLC - Total Product Life Cycle
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TPLC
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Device
device, intrauterine, contraceptive and introducer
Definition
Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86
Product Code
HDT
Regulation Number
884.5360
Device Class
3
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
1
1
2016
1
1
2018
1
1
2019
3
3
2020
4
4
2021
1
1
2022
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
7
7
Detachment of Device or Device Component
4
4
Component Missing
4
4
Migration or Expulsion of Device
2
2
Expulsion
1
1
Defective Device
1
1
Defective Component
1
1
Packaging Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Device Or Device Fragments Location Unknown
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
5
5
No Information
2
2
Device Embedded In Tissue or Plaque
2
2
Failure of Implant
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Blood Loss
1
1
Foreign Body In Patient
1
1
Insufficient Information
1
1
Scar Tissue
1
1
Pain
1
1
Renal Failure
1
1
Hemorrhage/Bleeding
1
1
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