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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bag, drainage, with adhesive, ostomy
Product CodeFON
Regulation Number 876.5900
Device Class 1

MDR Year MDR Reports MDR Events
2022 13 13
2023 2 2
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 5 5
Sharp Edges 4 4
Material Disintegration 4 4
Material Protrusion/Extrusion 4 4
Obstruction of Flow 3 3
Improper or Incorrect Procedure or Method 3 3
Contamination /Decontamination Problem 2 2
Partial Blockage 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Difficult to Remove 1 1
Fluid/Blood Leak 1 1
Device Contaminated During Manufacture or Shipping 1 1
Positioning Problem 1 1
Gas/Air Leak 1 1
Material Too Soft/Flexible 1 1
Tear, Rip or Hole in Device Packaging 1 1
Melted 1 1
Material Too Rigid or Stiff 1 1
Defective Device 1 1
Complete Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Skin Inflammation/ Irritation 6 6
Pain 6 6
Hypersensitivity/Allergic reaction 2 2
Rash 2 2
Skin Infection 2 2
Erythema 2 2
Hemorrhage/Bleeding 2 2
Swelling/ Edema 2 2
Tissue Breakdown 1 1
Obstruction/Occlusion 1 1
Fungal Infection 1 1
Pneumothorax 1 1
Itching Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II Mar-21-2024
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