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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
2021 118 118
2022 94 94
2023 90 90
2024 53 53
2025 104 104
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 200 200
Malposition of Device 151 151
Material Too Rigid or Stiff 68 68
Positioning Problem 33 33
Fluid/Blood Leak 23 23
Appropriate Term/Code Not Available 20 20
Adverse Event Without Identified Device or Use Problem 15 15
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
Break 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 Clinical Signs, Symptoms or Conditions 188 188
Abrasion 135 135
Skin Inflammation/ Irritation 58 58
Hemorrhage/Bleeding 35 35
Pain 33 33
No Consequences Or Impact To Patient 22 22
Pressure Sores 20 20
Blister 9 9
No Patient Involvement 9 9
Tissue Breakdown 8 8
Urinary Tract Infection 7 7
Distress 7 7
Itching Sensation 6 6
Erythema 5 5
Rash 4 4
Discomfort 4 4
Hypersensitivity/Allergic reaction 3 3
Laceration(s) 2 2
Granuloma 2 2
Unspecified Infection 1 1
Urticaria 1 1
Skin Infection 1 1
Drug Resistant Bacterial Infection 1 1
Emotional Changes 1 1
Fungal Infection 1 1
Necrosis 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
Ulcer 1 1
Bacterial Infection 1 1

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