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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, femoral
Product CodeLFK
Regulation Number 876.5540
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 2 2
Separation Problem 2 2
Entrapment of Device 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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