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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rod, colostomy
Product CodeEZP
Regulation Number 876.4270
Device Class 2

MDR Year MDR Reports MDR Events
2017 1 1
2019 1 1
2022 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Packaging Problem 2 2
Delivered as Unsterile Product 2 2
Unsealed Device Packaging 2 2
Product Quality Problem 1 1
Entrapment of Device 1 1
Material Fragmentation 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Necrosis 5 5
Hemorrhage/Bleeding 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Swelling/ Edema 2 2
Pain 2 2
Tissue Damage 1 1
Rupture 1 1
Foreign Body In Patient 1 1
Gastrointestinal Hemorrhage 1 1
Insufficient Information 1 1

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