TPLC - Total Product Life Cycle

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Device	bag, drainage, with adhesive, ostomy
Regulation Description	Ostomy pouch and accessories.
Product Code	FON
Regulation Number	876.5900
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Protrusion/Extrusion	37	37
Melted	34	34
Malposition of Device	32	32
Sharp Edges	20	20
Material Disintegration	10	10
Material Too Rigid or Stiff	6	6
Leak/Splash	5	5
Peeled/Delaminated	5	5
Positioning Failure	5	5
Fluid/Blood Leak	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Obstruction of Flow	3	3
Contamination /Decontamination Problem	2	2
Partial Blockage	2	2
Device Contaminated During Manufacture or Shipping	1	1
Off-Label Use	1	1
Complete Blockage	1	1
Material Erosion	1	1
Defective Device	1	1
Positioning Problem	1	1
Difficult to Remove	1	1
Gas/Air Leak	1	1
Material Separation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Material Too Soft/Flexible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	93	93
Pain	7	7
Skin Inflammation/ Irritation	6	6
Hemorrhage/Bleeding	6	6
Erythema	4	4
Skin Infection	3	3
Rash	3	3
Swelling/ Edema	3	3
Tissue Breakdown	3	3
Hypersensitivity/Allergic reaction	2	2
Fungal Infection	2	2
Itching Sensation	2	2
Cellulitis	2	2
Laceration(s)	2	2
Fluid Discharge	2	2
Pneumothorax	1	1
Obstruction/Occlusion	1	1
Ulcer	1	1
Pressure Sores	1	1
Granuloma	1	1