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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device urinal
Product CodeFNP
Regulation Number 880.6730
Device Class 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 4 4
2019 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 2 2
Scratched Material 2 2
Sharp Edges 1 1
Break 1 1
Material Frayed 1 1
Product Quality Problem 1 1
Material Protrusion/Extrusion 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Injury 2 2
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Tissue Damage 1 1

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