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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, manual, specialized obstetric-gynecologic
Product CodeKNA
Regulation Number 884.4530
Device Class 2

MDR Year MDR Reports MDR Events
2019 5 5
2021 2 2
2022 4 4
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Deflation Problem 2 2
Output Problem 2 2
Migration 1 1
Fracture 1 1
Material Fragmentation 1 1
Material Rupture 1 1
Tear, Rip or Hole in Device Packaging 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 4 4
Insufficient Information 1 1
Scar Tissue 1 1
Perforation of Vessels 1 1

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