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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
Product CodeEXH
Regulation Number 876.5900
Device Class 1

MDR Year MDR Reports MDR Events
2018 112 112
2019 93 93
2020 89 89
2021 2 2
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 278 278
Material Disintegration 11 11
Fluid Leak 9 9
Positioning Problem 9 9
Adverse Event Without Identified Device or Use Problem 4 4
Complete Blockage 2 2
Insufficient Information 2 2
Sharp Edges 2 2
Material Separation 1 1
Delamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 240 240
No Patient Involvement 45 45
Laceration(s) 6 6
Tissue Damage 6 6
Blood Loss 5 5
Urinary Tract Infection 3 3
Erythema 2 2
Hemorrhage/Bleeding 2 2
Diaphoresis 1 1
Skin Tears 1 1
Tissue Breakdown 1 1
No Known Impact Or Consequence To Patient 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Burning Sensation 1 1
Chills 1 1
Pain 1 1
Peeling 1 1
Rash 1 1
Swelling 1 1
Cellulitis 1 1

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