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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bag, intestine
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 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 33 33
Break 16 16
Device Contaminated During Manufacture or Shipping 4 4
Material Protrusion/Extrusion 3 3
Material Separation 3 3
Burst Container or Vessel 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Puncture/Hole 2 2
Material Rupture 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Unraveled Material 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 49 49
No Consequences Or Impact To Patient 11 11
Insufficient Information 10 10
No Patient Involvement 2 2
Intraoperative Pain 1 1
Foreign Body In Patient 1 1
Exposure to Body Fluids 1 1
Capsular Contracture 1 1
Laceration(s) 1 1
Nerve Damage 1 1

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