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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 104 104
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 498 498
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 23 23
Appropriate Device Problem 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 Device Problem Information 3 3
Improper or Incorrect Procedure or Method 2 2
Leak/Splash 1 1
Off-Label Use 1 1
Material Erosion 1 1
Material Deformation 1 1
Device Handling Problem 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 188 188
Abrasion 135 135
Skin Inflammation/ Irritation 58 58
No Patient Involvement 44 44
Hemorrhage/Blood Loss/Bleeding 35 35
Pain 34 34
Distress 32 32
Tissue Damage 24 24
Blood Loss 22 22
Pressure Sore/Ulcer 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
Bacterial Infection 2 2
Granuloma 2 2
Unspecified Infection 1 1
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

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