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	2300	2300
Positioning Problem	380	380
Fluid/Blood Leak	218	218
Material Too Rigid or Stiff	187	187
Material Disintegration	110	110
Adverse Event Without Identified Device or Use Problem	71	72
Sharp Edges	58	58
Material Erosion	57	57
Positioning Failure	53	53
Leak/Splash	42	42
Complete Blockage	29	29
Material Protrusion/Extrusion	29	29
Device Handling Problem	27	27
Melted	27	27
Improper or Incorrect Procedure or Method	22	22
Material Split, Cut or Torn	21	21
Partial Blockage	20	20
Material Separation	16	16
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
Manufacturing, Packaging or Shipping Problem	5	5
Fire	3	3
Material Discolored	3	3
Insufficient Device Problem Information	3	3
Material Integrity 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	2189	2189
Tissue Breakdown	263	263
Hemorrhage/Blood Loss/Bleeding	208	208
Skin Inflammation/ Irritation	181	182
Erythema	118	119
No Consequences Or Impact To Patient	117	117
Laceration(s)	82	82
Discomfort	75	75
Pain	55	55
Obstruction/Occlusion	44	44
Blister	30	30
Fungal Infection	27	27
Distress	24	24
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	20	20
Cramp(s) /Muscle Spasm(s)	20	20
Rash	17	18
Itching Sensation	15	15
Skin Infection	14	14
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	9	9
Urinary Tract Infection	8	8
Tissue Damage	7	7
Pressure Sore/Ulcer	7	7
Swelling/ Edema	6	6
Blood Loss	6	6
Burn(s)	6	6
Bacterial Infection	5	5
Contact Dermatitis	5	5
Cellulitis	5	5
Skin Discoloration	5	5
Necrosis	4	4
Urticaria	4	5
Purulent Discharge	3	3
Inflammation	3	3
Partial thickness (Second Degree) Burn	3	3
Superficial (First Degree) Burn	3	3
Urinary Retention	2	2
Peeling	2	2
Abdominal Distention	2	2
Nodule	2	2
Granuloma	2	2
Skin Erosion	1	1
Local Reaction	1	1
Diarrhea	1	1
Asthma	1	1