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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
2016 66 66
2017 7 7
2018 342 342
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 1047 1047
Sharp Edges 96 96
Positioning Problem 78 78
Material Too Rigid or Stiff 78 78
Adverse Event Without Identified Device or Use Problem 56 56
Fluid/Blood Leak 42 42
Difficult to Remove 26 26
Appropriate Term/Code Not Available 20 20
Device Handling Problem 5 5
Product Quality Problem 5 5
Obstruction of Flow 4 4
Material Disintegration 4 4
Material Too Soft/Flexible 4 4
Material Protrusion/Extrusion 4 4
Device Operates Differently Than Expected 3 3
Insufficient Information 3 3
Scratched Material 2 2
Material Integrity Problem 2 2
Loss of or Failure to Bond 2 2
Inflation Problem 2 2
Nonstandard Device 2 2
Off-Label Use 2 2
Sticking 2 2
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Failure To Adhere Or Bond 1 1
Material Rupture 1 1
Material Puncture/Hole 1 1
Leak/Splash 1 1
Break 1 1
Burst Container or Vessel 1 1
Material Erosion 1 1
Patient-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1
Gas/Air Leak 1 1
Material Deformation 1 1
Temperature Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 738 738
No Clinical Signs, Symptoms or Conditions 166 166
No Patient Involvement 143 143
Tissue Damage 55 55
Skin Irritation 50 50
Skin Inflammation/ Irritation 48 48
Pain 36 36
Distress 32 32
Blood Loss 32 32
Hemorrhage/Bleeding 26 26
No Known Impact Or Consequence To Patient 24 24
Itching Sensation 18 18
Abrasion 17 17
Erythema 16 16
Rash 16 16
Tissue Breakdown 10 10
Fungal Infection 10 10
Laceration(s) 10 10
Skin Inflammation 9 9
Urinary Tract Infection 9 9
Blister 9 9
Skin Discoloration 7 7
Hypersensitivity/Allergic reaction 7 7
Discharge 6 6
Discomfort 6 6
Bacterial Infection 5 5
Unspecified Infection 3 3
Burning Sensation 3 3
Reaction 2 2
Urticaria 2 2
Pneumonia 2 2
Cellulitis 2 2
Granuloma 2 2
Aspiration/Inhalation 2 2
Skin Infection 2 2
No Information 1 1
Contact Dermatitis 1 1
Drug Resistant Bacterial Infection 1 1
Purulent Discharge 1 1
Emotional Changes 1 1
Necrosis 1 1
Inflammation 1 1
Skin Tears 1 1
Fluid Discharge 1 1
Ulcer 1 1
Ulceration 1 1

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