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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, abortion, vacuum
Product CodeHHI
Regulation Number 884.5070
Device Class 2

MDR Year MDR Reports MDR Events
2020 3 3
2021 3 3
2022 6 6
2023 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Delivered as Unsterile Product 2 2
Fitting Problem 1 1
Device Contamination with Body Fluid 1 1
Insufficient Information 1 1
Device Fell 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Clean Adequately 1 1
Microbial Contamination of Device 1 1
Shipping Damage or Problem 1 1
Failure to Power Up 1 1
Component Missing 1 1
Material Separation 1 1
Residue After Decontamination 1 1
Device Reprocessing Problem 1 1
Suction Problem 1 1
Loose or Intermittent Connection 1 1
Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 3 3
Foreign Body In Patient 2 2
Uterine Perforation 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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