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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, cervical, hygroscopic-laminaria
Product CodeHDY
Regulation Number 884.4260
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 3 3
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 4 4
Break 2 2
Fluid/Blood Leak 2 2
Leak/Splash 2 2
Loose or Intermittent Connection 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Foreign Body In Patient 2 2
Insufficient Information 2 2
Blood Loss 1 1

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