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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
2020 14 14
2021 14 14
2022 20 20
2023 17 17
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 31 31
Break 24 24
Device Contaminated During Manufacture or Shipping 5 5
Material Separation 4 4
Material Protrusion/Extrusion 4 4
Material Rupture 3 3
Material Fragmentation 2 2
Material Puncture/Hole 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Fell 1 1
Component Missing 1 1
Extra Components 1 1
Unraveled Material 1 1
Burst Container or Vessel 1 1
Fluid/Blood Leak 1 1
Detachment of Device or Device Component 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 60 60
Insufficient Information 13 13
No Consequences Or Impact To Patient 5 5
Foreign Body In Patient 2 2
No Patient Involvement 2 2
Capsular Contracture 1 1
Nerve Damage 1 1
Exposure to Body Fluids 1 1
Laceration(s) 1 1
Intraoperative Pain 1 1

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