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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pouch, colostomy
Product CodeEZQ
Regulation Number 876.5900
Device Class 1

MDR Year MDR Reports MDR Events
2019 246 246
2020 381 381
2021 118 118
2022 94 94
2023 90 90
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 713 713
Sharp Edges 95 95
Positioning Problem 78 78
Material Too Rigid or Stiff 69 69
Fluid/Blood Leak 40 40
Adverse Event Without Identified Device or Use Problem 26 26
Appropriate Term/Code Not Available 20 20
Material Too Soft/Flexible 4 4
Obstruction of Flow 4 4
Material Protrusion/Extrusion 4 4
Material Disintegration 3 3
Insufficient Information 3 3
Loss of or Failure to Bond 2 2
Material Integrity Problem 2 2
Product Quality Problem 2 2
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Gas/Air Leak 1 1
Material Deformation 1 1
Break 1 1
Burst Container or Vessel 1 1
Material Erosion 1 1
Leak/Splash 1 1
Nonstandard Device 1 1
Off-Label Use 1 1
Device Handling Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 482 482
No Clinical Signs, Symptoms or Conditions 165 165
No Patient Involvement 89 89
Skin Inflammation/ Irritation 48 48
Tissue Damage 40 40
Pain 35 35
Distress 32 32
Hemorrhage/Bleeding 25 25
Blood Loss 22 22
Abrasion 15 15
Skin Irritation 13 13
Blister 9 9
Itching Sensation 9 9
Tissue Breakdown 8 8
Erythema 7 7
Rash 7 7
Urinary Tract Infection 7 7
Laceration(s) 6 6
Hypersensitivity/Allergic reaction 5 5
No Known Impact Or Consequence To Patient 4 4
Discomfort 4 4
Reaction 2 2
Fungal Infection 2 2
Urticaria 2 2
Unspecified Infection 2 2
Cellulitis 2 2
Granuloma 2 2
Necrosis 1 1
Burning Sensation 1 1
Purulent Discharge 1 1
Emotional Changes 1 1
Bacterial Infection 1 1
Inflammation 1 1
Ulcer 1 1
Skin Inflammation 1 1
Skin Infection 1 1
Contact Dermatitis 1 1
Drug Resistant Bacterial Infection 1 1

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