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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pouch, colostomy
Regulation Description Ostomy pouch and accessories.
Product CodeEZQ
Regulation Number 876.5900
Device Class 1

MDR Year MDR Reports MDR Events
2016 66 66
2017 7 7
2018 342 342
2019 246 246
2020 381 381
2021 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 966 966
Sharp Edges 78 78
Positioning Problem 47 47
Adverse Event Without Identified Device or Use Problem 46 46
Fluid Leak 27 27
Difficult to Remove 26 26
Material Too Rigid or Stiff 10 10
Product Quality Problem 4 4
Device Handling Problem 4 4
Device Operates Differently Than Expected 3 3
Material Integrity Problem 2 2
Scratched Material 2 2
Sticking 2 2
Inflation Problem 2 2
Nonstandard Device 2 2
Loss of or Failure to Bond 2 2
Break 1 1
Burst Container or Vessel 1 1
Material Disintegration 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Use of Device Problem 1 1
Patient-Device Incompatibility 1 1
Failure To Adhere Or Bond 1 1
Material Rupture 1 1
Temperature Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 738 738
No Patient Involvement 143 143
No Clinical Signs, Symptoms or Conditions 65 65
Tissue Damage 55 55
Skin Irritation 50 50
Blood Loss 32 32
Distress 25 25
No Known Impact Or Consequence To Patient 24 24
Itching Sensation 15 15
Rash 13 13
Erythema 13 13
Laceration(s) 10 10
Fungal Infection 9 9
Skin Inflammation 9 9
Skin Discoloration 7 7
Hypersensitivity/Allergic reaction 6 6
Discharge 6 6
Tissue Breakdown 6 6
Bacterial Infection 4 4
Pain 4 4
Unspecified Infection 3 3
Discomfort 3 3
Burning Sensation 3 3
Reaction 2 2
Urinary Tract Infection 2 2
Hemorrhage/Bleeding 2 2
Abrasion 2 2
Aspiration/Inhalation 2 2
Pneumonia 2 2
Ulceration 1 1
Cellulitis 1 1
Inflammation 1 1
Ulcer 1 1
Urticaria 1 1
Skin Tears 1 1
No Information 1 1
Skin Infection 1 1
Contact Dermatitis 1 1
Fluid Discharge 1 1

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