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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, breast, non-powered
Product CodeHGY
Regulation Number 884.5150
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 5 5
2022 1 1
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Suction Problem 2 2
Gas/Air Leak 1 1
Failure to Power Up 1 1
Material Puncture/Hole 1 1
Patient Device Interaction Problem 1 1
Suction Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Breast Discomfort/Pain 6 6
Inflammation 4 4
Injury 1 1
Skin Tears 1 1
Skin Inflammation/ Irritation 1 1
Insufficient Information 1 1
Unspecified Infection 1 1

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