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	10572	10572
Positioning Problem	1359	1359
Fluid/Blood Leak	538	538
Material Too Rigid or Stiff	172	172
Material Disintegration	151	151
Adverse Event Without Identified Device or Use Problem	96	96
Sharp Edges	67	67
Material Erosion	53	53
Complete Blockage	34	34
Device Handling Problem	33	33
Leak/Splash	32	32
Melted	24	24
Material Protrusion/Extrusion	22	22
Material Split, Cut or Torn	21	21
Partial Blockage	20	20
Material Separation	19	19
Improper or Incorrect Procedure or Method	18	18
Physical Resistance/Sticking	14	14
Activation, Positioning or Separation Problem	13	13
Separation Problem	13	13
Obstruction of Flow	12	12
Material Too Soft/Flexible	10	10
Off-Label Use	8	8
Flare or Flash	7	7
Insufficient Information	4	4
Fire	3	3
Crack	1	1
Unintended Movement	1	1
Material Integrity Problem	1	1
Material Fragmentation	1	1
Packaging Problem	1	1
Device Emits Odor	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	5673	5673
No Patient Involvement	2711	2711
No Clinical Signs, Symptoms or Conditions	1949	1949
Tissue Breakdown	263	263
Tissue Damage	188	188
Hemorrhage/Bleeding	183	183
Erythema	143	143
Blood Loss	141	141
Skin Inflammation/ Irritation	135	135
Skin Irritation	123	123
Laceration(s)	106	106
Discomfort	93	93
Pain	62	62
Obstruction/Occlusion	49	49
Distress	30	30
Blister	29	29
Fungal Infection	27	27
Rash	23	23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Cramp(s) /Muscle Spasm(s)	20	20
Itching Sensation	16	16
Abrasion	14	14
Skin Tears	13	13
Ulcer	13	13
Skin Infection	11	11
Unspecified Infection	11	11
Fluid Discharge	10	10
Hypersensitivity/Allergic reaction	10	10
Urinary Tract Infection	9	9
Bacterial Infection	8	8
Burning Sensation	8	8
Anxiety	7	7
Necrosis	7	7
Pressure Sores	7	7
Cellulitis	7	7
Swelling/ Edema	6	6
Burn(s)	6	6
Injury	6	6
Urinary Retention	6	6
Skin Discoloration	5	5
Bruise/Contusion	5	5
Contact Dermatitis	4	4
Inflammation	4	4
Urticaria	4	4
Irritation	3	3
Purulent Discharge	3	3
Peeling	2	2
Reaction	2	2
Discharge	2	2
Abdominal Distention	2	2