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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device protector, ostomy
Regulation Description Ostomy pouch and accessories.
Product CodeEXE
Regulation Number 876.5900
Device Class 1

MDR Year MDR Reports MDR Events
2020 8667 8667
2021 1144 1144
2022 547 547
2023 360 360
2024 295 295
2025 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 10498 10498
Positioning Problem 1359 1359
Fluid/Blood Leak 525 525
Material Too Rigid or Stiff 171 171
Material Disintegration 135 135
Adverse Event Without Identified Device or Use Problem 92 92
Sharp Edges 67 67
Material Erosion 53 53
Complete Blockage 34 34
Device Handling Problem 33 33
Leak/Splash 32 32
Melted 24 24
Material Protrusion/Extrusion 22 22
Material Split, Cut or Torn 21 21
Partial Blockage 20 20
Material Separation 18 18
Improper or Incorrect Procedure or Method 18 18
Physical Resistance/Sticking 14 14
Activation, Positioning or Separation Problem 13 13
Separation Problem 13 13
Obstruction of Flow 12 12
Material Too Soft/Flexible 10 10
Off-Label Use 7 7
Flare or Flash 7 7
Insufficient Information 4 4
Fire 2 2
Device Dislodged or Dislocated 1 1
Unintended Movement 1 1
Packaging Problem 1 1
Device Emits Odor 1 1
Crack 1 1
Material Integrity Problem 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5673 5673
No Patient Involvement 2711 2711
No Clinical Signs, Symptoms or Conditions 1875 1875
Tissue Breakdown 253 253
Tissue Damage 188 188
Hemorrhage/Bleeding 183 183
Erythema 141 141
Blood Loss 141 141
Skin Inflammation/ Irritation 134 134
Skin Irritation 123 123
Laceration(s) 106 106
Discomfort 92 92
Pain 60 60
Obstruction/Occlusion 47 47
Distress 30 30
Blister 29 29
Fungal Infection 26 26
Rash 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Cramp(s) /Muscle Spasm(s) 20 20
Itching Sensation 15 15
Abrasion 14 14
Ulcer 13 13
Skin Tears 12 12
Skin Infection 11 11
Unspecified Infection 11 11
Hypersensitivity/Allergic reaction 10 10
Fluid Discharge 9 9
Urinary Tract Infection 9 9
Burning Sensation 8 8
Bacterial Infection 8 8
Anxiety 7 7
Necrosis 7 7
Injury 6 6
Pressure Sores 6 6
Burn(s) 6 6
Cellulitis 6 6
Urinary Retention 6 6
Bruise/Contusion 5 5
Swelling/ Edema 5 5
Inflammation 4 4
Contact Dermatitis 4 4
Urticaria 3 3
Purulent Discharge 3 3
Skin Discoloration 3 3
Irritation 3 3
Reaction 2 2
Abdominal Distention 2 2
Discharge 2 2
Superficial (First Degree) Burn 2 2

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II Jan-10-2025
2 ConvaTec, Inc II May-25-2022
3 T.G. Eakin Limited III Sep-25-2024
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