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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, ventricular, general & plastic surgery
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGBS
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 4 4
2018 2 2
2019 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Detachment Of Device Component 1 1
Difficult to Insert 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Foreign Body In Patient 3 3
No Information 2 2
Device Embedded In Tissue or Plaque 1 1
Uterine Perforation 1 1
No Patient Involvement 1 1
Hematoma 1 1

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