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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
Regulation Description Vacuum abortion system.
Product CodeHHI
Regulation Number 884.5070
Device Class 2

MDR Year MDR Reports MDR Events
2021 3 3
2022 6 6
2023 1 1
2024 3 3
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Delivered as Unsterile Product 2 2
Insufficient Device Problem Information 1 1
Device Reprocessing Problem 1 1
Failure to Clean Adequately 1 1
Suction Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Contamination with Body Fluid 1 1
Microbial Contamination of Device 1 1
Residue After Decontamination 1 1
Device Damaged Prior to Receipt by User 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Blood Loss/Bleeding 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 3 3
Uterine Perforation 3 3
Foreign Body In Patient 2 2

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