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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 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 720 720
Sharp Edges 116 116
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
Obstruction of Flow 4 4
Material Too Soft/Flexible 4 4
Material Protrusion/Extrusion 4 4
Material Disintegration 3 3
Insufficient Information 3 3
Material Integrity Problem 2 2
Product Quality Problem 2 2
Loss of or Failure to Bond 2 2
Material Erosion 1 1
Use of Device Problem 1 1
Gas/Air Leak 1 1
Nonstandard Device 1 1
Improper or Incorrect Procedure or Method 1 1
Leak/Splash 1 1
Burst Container or Vessel 1 1
Break 1 1
Off-Label Use 1 1
Device Handling Problem 1 1
Material Deformation 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 172 172
No Patient Involvement 89 89
Skin Inflammation/ Irritation 48 48
Tissue Damage 40 40
Abrasion 35 35
Pain 35 35
Distress 32 32
Hemorrhage/Bleeding 25 25
Blood Loss 22 22
Skin Irritation 13 13
Itching Sensation 9 9
Blister 9 9
Tissue Breakdown 8 8
Rash 7 7
Erythema 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
Unspecified Infection 2 2
Urticaria 2 2
Fungal Infection 2 2
Cellulitis 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
Purulent Discharge 1 1
Burning Sensation 1 1
Skin Inflammation 1 1
Contact Dermatitis 1 1
Bacterial Infection 1 1

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