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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cannula, ventricular
Regulation Description Ventricular cannula.
Product CodeHCD
Regulation Number 882.4060
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2018 6 6
2019 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Material Protrusion/Extrusion 6 6
Tip 1 1
Break 1 1
Crack 1 1
Scratched Material 1 1
Sharp Edges 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
Fistula 6 6
Pseudoaneurysm 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Aneurysm 1 1

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