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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aspirator, endometrial
Product CodeHFF
Regulation Number 884.1060
Device Class 2

MDR Year MDR Reports MDR Events
2016 6 6
2017 3 3
2018 1 1
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 6 6
Improper or Incorrect Procedure or Method 4 4
Detachment of Device or Device Component 2 2
Break 1 1
Detachment Of Device Component 1 1
Material Fragmentation 1 1
Inflation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 11 11
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Pain 1 1
No Consequences Or Impact To Patient 1 1

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