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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
Product CodeGBS
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
Device Handling Problem 1 1
Break 1 1
Particulates 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Tamponade 3 3
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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