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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, oxygen, aqueous
Product CodeMWG
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
2 4 2 2 7 0

MDR Year MDR Reports MDR Events
2022 5 5
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Fluid/Blood Leak 2 2
Material Puncture/Hole 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Thrombosis/Thrombus 7 7
Chest Pain 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Obstruction/Occlusion 1 1

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