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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
2014 88 88
2015 27 27
2016 9 9
2018 112 112
2019 93 93
2020 89 89
2021 2 2
2022 10 10
2023 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 301 301
Adverse Event Without Identified Device or Use Problem 47 47
Occlusion Within Device 22 22
Fluid/Blood Leak 13 13
Material Disintegration 12 12
Appropriate Term/Code Not Available 11 11
No Flow 9 9
Human-Device Interface Problem 9 9
Positioning Problem 9 9
Sharp Edges 8 8
Deflation Problem 7 7
Device Operates Differently Than Expected 6 6
Difficult to Remove 5 5
Insufficient Information 4 4
Leak/Splash 4 4
Partial Blockage 2 2
Complete Blockage 2 2
Blocked Connection 2 2
Increased Sensitivity 2 2
Connection Problem 2 2
Use of Device Problem 1 1
Delamination 1 1
Loss of or Failure to Bond 1 1
Defective Component 1 1
Improper or Incorrect Procedure or Method 1 1
Product Quality Problem 1 1
Failure To Adhere Or Bond 1 1
Material Integrity Problem 1 1
Crack 1 1
Defective Device 1 1
Split 1 1
Break 1 1
Material Erosion 1 1
Insufficient Flow or Under Infusion 1 1
Material Separation 1 1
Device Contamination with Chemical or Other Material 1 1
Reflux within Device 1 1
Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 252 252
No Known Impact Or Consequence To Patient 47 47
No Patient Involvement 46 46
No Clinical Signs, Symptoms or Conditions 28 28
Rash 23 23
Itching Sensation 14 14
Tissue Damage 14 14
Urinary Tract Infection 10 10
Erythema 10 10
Skin Discoloration 8 8
Blood Loss 8 8
Skin Irritation 7 7
Discomfort 6 6
Laceration(s) 6 6
Pain 6 6
Irritation 5 5
Burning Sensation 5 5
Skin Erosion 3 3
Hemorrhage/Bleeding 3 3
Skin Tears 3 3
Fungal Infection 3 3
Skin Inflammation 3 3
Tissue Breakdown 2 2
No Information 2 2
Unspecified Infection 2 2
Fungus 2 2
Bacterial Infection 2 2
Cellulitis 1 1
Fever 1 1
Hematoma 1 1
Inflammation 1 1
Abrasion 1 1
Sepsis 1 1
Peeling 1 1
Swelling 1 1
Vomiting 1 1
Ulceration 1 1
Urinary Retention 1 1
Chills 1 1
Reaction 1 1
Wheal(s) 1 1
Ulcer 1 1
Urticaria 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1
Diaphoresis 1 1
Obstruction/Occlusion 1 1

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