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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
2023 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
Difficult to Insert 1 1
Improper or Incorrect Procedure or Method 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Clinical Signs, Symptoms or Conditions 1 1
Hemorrhage/Bleeding 1 1
Needle Stick/Puncture 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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