TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Malposition of Device	2232	2232
Positioning Problem	390	390
Fluid/Blood Leak	218	218
Material Too Rigid or Stiff	175	175
Material Disintegration	95	95
Adverse Event Without Identified Device or Use Problem	70	70
Sharp Edges	58	58
Material Erosion	56	56
Leak/Splash	33	33
Positioning Failure	30	30
Device Handling Problem	27	27
Melted	27	27
Complete Blockage	24	24
Material Protrusion/Extrusion	24	24
Material Split, Cut or Torn	21	21
Improper or Incorrect Procedure or Method	21	21
Partial Blockage	20	20
Material Separation	15	15
Physical Resistance/Sticking	14	14
Activation, Positioning or Separation Problem	13	13
Separation Problem	13	13
Obstruction of Flow	12	12
Device Damaged Prior to Use	9	9
Flare or Flash	9	9
Off-Label Use	8	8
Material Too Soft/Flexible	7	7
Fire	3	3
Insufficient Information	3	3
Material Discolored	3	3
Break	1	1
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Use of Device Problem	1	1
Packaging Problem	1	1
Device Emits Odor	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2102	2102
Tissue Breakdown	241	241
Hemorrhage/Bleeding	186	186
Skin Inflammation/ Irritation	159	159
No Consequences Or Impact To Patient	117	117
Erythema	116	116
Laceration(s)	80	80
Discomfort	71	71
Pain	54	54
Obstruction/Occlusion	44	44
Blister	30	30
Fungal Infection	27	27
Distress	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Cramp(s) /Muscle Spasm(s)	20	20
Itching Sensation	15	15
Rash	15	15
Skin Infection	13	13
Skin Tears	13	13
Ulcer	13	13
Abrasion	13	13
Skin Irritation	10	10
Fluid Discharge	10	10
Hypersensitivity/Allergic reaction	9	9
Burning Sensation	8	8
Urinary Tract Infection	7	7
Pressure Sores	7	7
Tissue Damage	7	7
Swelling/ Edema	6	6
Blood Loss	6	6
Burn(s)	6	6
Contact Dermatitis	5	5
Cellulitis	5	5
Skin Discoloration	5	5
Necrosis	4	4
Bacterial Infection	4	4
Partial thickness (Second Degree) Burn	3	3
Purulent Discharge	3	3
Inflammation	3	3
Superficial (First Degree) Burn	3	3
Urticaria	3	3
Urinary Retention	2	2
Peeling	2	2
Abdominal Distention	2	2
Diarrhea	1	1
Skin Erosion	1	1
Local Reaction	1	1
Dyspnea	1	1
Asthma	1	1
Reaction	1	1