TPLC - Total Product Life Cycle

show TPLC since

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	10648	10648
Positioning Problem	1359	1359
Fluid/Blood Leak	544	544
Material Too Rigid or Stiff	204	204
Material Disintegration	154	154
Adverse Event Without Identified Device or Use Problem	101	101
Sharp Edges	73	73
Material Erosion	54	54
Complete Blockage	37	37
Leak/Splash	33	33
Device Handling Problem	33	33
Melted	27	27
Material Protrusion/Extrusion	25	25
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
Device Damaged Prior to Use	9	9
Off-Label Use	8	8
Flare or Flash	8	8
Positioning Failure	5	5
Insufficient Information	4	4
Fire	3	3
Break	1	1
Crack	1	1
Unintended Movement	1	1
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Fragmentation	1	1
Use of Device Problem	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	2062	2062
Tissue Breakdown	271	271
Tissue Damage	188	188
Hemorrhage/Bleeding	183	183
Erythema	146	146
Blood Loss	141	141
Skin Inflammation/ Irritation	136	136
Skin Irritation	123	123
Laceration(s)	106	106
Discomfort	93	93
Pain	69	69
Obstruction/Occlusion	49	49
Distress	30	30
Fungal Infection	30	30
Blister	29	29
Rash	26	26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Cramp(s) /Muscle Spasm(s)	20	20
Itching Sensation	17	17
Abrasion	14	14
Skin Tears	13	13
Ulcer	13	13
Skin Infection	12	12
Hypersensitivity/Allergic reaction	11	11
Unspecified Infection	11	11
Fluid Discharge	10	10
Bacterial Infection	9	9
Burning Sensation	9	9
Urinary Tract Infection	9	9
Anxiety	7	7
Necrosis	7	7
Pressure Sores	7	7
Cellulitis	7	7
Swelling/ Edema	6	6
Skin Discoloration	6	6
Burn(s)	6	6
Injury	6	6
Urinary Retention	6	6
Bruise/Contusion	5	5
Contact Dermatitis	4	4
Inflammation	4	4
Urticaria	4	4
Irritation	3	3
Purulent Discharge	3	3
Partial thickness (Second Degree) Burn	3	3
Peeling	2	2
Reaction	2	2
Discharge	2	2