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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device surgical table cushion
Regulation Description Manual operating table and accessories and manual operating chair and accessories.
Product CodeLWG
Regulation Number 878.4950
Device Class 1

MDR Year MDR Reports MDR Events
2022 1 2
2024 1 1
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 8 8
Material Separation 3 3
Detachment of Device or Device Component 2 3
Break 1 1
Insufficient Information 1 1
Unraveled Material 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
Insufficient Information 2 3
Sepsis 1 1
Hemorrhage/Bleeding 1 1

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