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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
2020 381 381
2021 118 118
2022 94 94
2023 90 90
2024 53 53
2025 100 100

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 484 484
Sharp Edges 226 226
Material Too Rigid or Stiff 69 69
Positioning Problem 59 59
Fluid/Blood Leak 30 30
Adverse Event Without Identified Device or Use Problem 22 22
Appropriate Term/Code Not Available 20 20
Obstruction of Flow 4 4
Material Protrusion/Extrusion 4 4
Material Too Soft/Flexible 4 4
Material Disintegration 3 3
Insufficient Information 3 3
Improper or Incorrect Procedure or Method 2 2
Leak/Splash 1 1
Off-Label Use 1 1
Material Erosion 1 1
Gas/Air Leak 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 315 315
No Clinical Signs, Symptoms or Conditions 173 173
Abrasion 135 135
Skin Inflammation/ Irritation 58 58
No Patient Involvement 44 44
Hemorrhage/Bleeding 35 35
Pain 34 34
Distress 32 32
Tissue Damage 24 24
Blood Loss 22 22
Pressure Sores 20 20
Blister 9 9
Itching Sensation 8 8
Tissue Breakdown 8 8
Erythema 7 7
Urinary Tract Infection 7 7
Rash 6 6
Laceration(s) 5 5
Hypersensitivity/Allergic reaction 4 4
Discomfort 4 4
Urticaria 2 2
Skin Irritation 2 2
Fungal Infection 2 2
Reaction 2 2
Ulcer 2 2
Granuloma 2 2
Skin Infection 1 1
Drug Resistant Bacterial Infection 1 1
Emotional Changes 1 1
Necrosis 1 1
Inflammation 1 1
Embolism/Embolus 1 1
Purulent Discharge 1 1
Cellulitis 1 1
Skin Discoloration 1 1
Burning Sensation 1 1
Contact Dermatitis 1 1
Nodule 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II Oct-24-2022
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