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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bag, intestine
Regulation Description Organ bag.
Product CodeKGY
Regulation Number 878.4100
Device Class 1

MDR Year MDR Reports MDR Events
2021 14 14
2022 20 20
2023 17 17
2024 18 18
2025 14 14
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 32 32
Break 22 22
Material Protrusion/Extrusion 5 5
Material Separation 4 4
Device Contaminated During Manufacture or Shipping 3 3
Material Puncture/Hole 3 3
Material Rupture 3 3
Burst Container or Vessel 2 2
Material Fragmentation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Detachment of Device or Device Component 2 2
Unraveled Material 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Material Deformation 1 1
Premature Separation 1 1
Fluid/Blood Leak 1 1
Extra Components 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67 67
Insufficient Information 17 17
Foreign Body In Patient 2 2
Exposure to Body Fluids 1 1
Capsular Contracture 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Intraoperative Pain 1 1

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