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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
2019 6 6
2020 14 14
2021 14 14
2022 20 20
2023 17 17
2024 18 18
2025 14 14
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 44 44
Break 27 27
Burst Container or Vessel 5 5
Device Contaminated During Manufacture or Shipping 5 5
Material Protrusion/Extrusion 5 5
Material Puncture/Hole 4 4
Material Separation 4 4
Material Rupture 3 3
Material Fragmentation 2 2
Detachment of Device or Device Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Deformation 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Premature Separation 1 1
Extra Components 1 1
Fluid/Blood Leak 1 1
Unraveled Material 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 77 77
Insufficient Information 19 19
No Consequences Or Impact To Patient 11 11
Foreign Body In Patient 2 2
No Patient Involvement 2 2
Intraoperative Pain 1 1
Exposure to Body Fluids 1 1
Nerve Damage 1 1
Laceration(s) 1 1
Capsular Contracture 1 1

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