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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
dilator, cervical, hygroscopic-laminaria
Product Code
HDY
Regulation Number
884.4260
Device Class
2
MDR Year
MDR Reports
MDR Events
2015
3
3
2017
1
1
2018
2
2
2019
1
1
2020
1
1
2021
3
3
2022
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
4
4
Leak/Splash
3
3
Other (for use when an appropriate device code cannot be identified)
3
3
Fluid/Blood Leak
2
2
Break
2
2
Difficult to Remove
1
1
Appropriate Term/Code Not Available
1
1
Structural Problem
1
1
Burst Container or Vessel
1
1
Material Puncture/Hole
1
1
Material Integrity Problem
1
1
Material Fragmentation
1
1
Material Protrusion/Extrusion
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3
3
Foreign Body In Patient
3
3
Chorioamnionitis
2
2
No Known Impact Or Consequence To Patient
2
2
Insufficient Information
2
2
No Code Available
1
1
Other (for use when an appropriate patient code cannot be identified)
1
1
Blood Loss
1
1
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