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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device protector, ostomy
Product CodeEXE
Regulation Number 876.5900
Device Class 1

MDR Year MDR Reports MDR Events
2019 16647 16647
2020 8667 8667
2021 1144 1144
2022 547 547
2023 360 360
2024 208 208

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 26960 26960
Positioning Problem 1899 1899
Fluid/Blood Leak 749 749
Material Too Rigid or Stiff 176 176
Material Disintegration 143 143
Adverse Event Without Identified Device or Use Problem 118 118
Sharp Edges 94 94
Material Erosion 53 53
Device Handling Problem 36 36
Leak/Splash 32 32
Material Separation 29 29
Complete Blockage 27 27
Melted 24 24
Material Split, Cut or Torn 21 21
Partial Blockage 20 20
Improper or Incorrect Procedure or Method 17 17
Material Protrusion/Extrusion 15 15
Physical Resistance/Sticking 14 14
Separation Problem 13 13
Activation, Positioning or Separation Problem 13 13
Material Too Soft/Flexible 10 10
Flare or Flash 7 7
Off-Label Use 7 7
Obstruction of Flow 5 5
Insufficient Information 4 4
Material Puncture/Hole 3 3
Use of Device Problem 3 3
Fire 2 2
Product Quality Problem 2 2
Crack 1 1
Unintended Movement 1 1
Material Integrity Problem 1 1
Material Fragmentation 1 1
Migration or Expulsion of Device 1 1
Structural Problem 1 1
Packaging Problem 1 1
Device Emits Odor 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 14785 14785
No Patient Involvement 9852 9852
No Clinical Signs, Symptoms or Conditions 1805 1805
Skin Irritation 318 318
Tissue Damage 298 298
Tissue Breakdown 271 271
Blood Loss 230 230
Hemorrhage/Bleeding 180 180
Laceration(s) 148 148
Erythema 138 138
Skin Inflammation/ Irritation 131 131
Pain 128 128
Discomfort 96 96
Itching Sensation 46 46
Obstruction/Occlusion 40 40
Rash 37 37
Distress 30 30
Fungal Infection 26 26
Blister 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Cramp(s) /Muscle Spasm(s) 20 20
No Known Impact Or Consequence To Patient 18 18
Abrasion 17 17
Skin Tears 13 13
Unspecified Infection 12 12
Ulcer 12 12
Hypersensitivity/Allergic reaction 10 10
Fluid Discharge 10 10
Urinary Tract Infection 9 9
Bacterial Infection 8 8
Burning Sensation 8 8
Skin Infection 8 8
Anxiety 7 7
Necrosis 7 7
Burn(s) 6 6
Injury 6 6
Urinary Retention 6 6
Bruise/Contusion 6 6
Cellulitis 5 5
Swelling/ Edema 5 5
Pressure Sores 5 5
Inflammation 4 4
Reaction 4 4
Skin Discoloration 3 3
Irritation 3 3
Purulent Discharge 3 3
Abdominal Distention 2 2
Peeling 2 2
Contact Dermatitis 2 2
Discharge 2 2

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II May-25-2022
2 ConvaTec, Inc II Oct-29-2019
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