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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bag, urinary, ileostomy
Regulation Description Ostomy pouch and accessories.
Product CodeEXH
Regulation Number 876.5900
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 10 10
2023 28 28
2024 59 59
2025 13 13
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 93 93
Sharp Edges 9 9
Adverse Event Without Identified Device or Use Problem 5 5
Material Disintegration 1 1
Material Erosion 1 1
Insufficient Information 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 77 77
Hemorrhage/Bleeding 25 25
Discomfort 8 8
Urinary Tract Infection 4 4
Erythema 2 2
Pain 2 2
Skin Infection 1 1
Diaphoresis 1 1
Sepsis 1 1
Skin Inflammation/ Irritation 1 1
Itching Sensation 1 1
Chills 1 1
Burning Sensation 1 1
Peeling 1 1
Abscess 1 1
Tissue Breakdown 1 1

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