TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Malposition of Device	26960	26960
Positioning Problem	1899	1899
Fluid/Blood Leak	749	749
Material Too Rigid or Stiff	176	176
Material Disintegration	143	143
Adverse Event Without Identified Device or Use Problem	118	118
Sharp Edges	94	94
Material Erosion	53	53
Device Handling Problem	36	36
Leak/Splash	32	32
Material Separation	29	29
Complete Blockage	27	27
Melted	24	24
Material Split, Cut or Torn	21	21
Partial Blockage	20	20
Improper or Incorrect Procedure or Method	17	17
Material Protrusion/Extrusion	15	15
Physical Resistance/Sticking	14	14
Separation Problem	13	13
Activation, Positioning or Separation Problem	13	13
Material Too Soft/Flexible	10	10
Flare or Flash	7	7
Off-Label Use	7	7
Obstruction of Flow	5	5
Insufficient Information	4	4
Material Puncture/Hole	3	3
Use of Device Problem	3	3
Fire	2	2
Product Quality Problem	2	2
Crack	1	1
Unintended Movement	1	1
Material Integrity Problem	1	1
Material Fragmentation	1	1
Migration or Expulsion of Device	1	1
Structural Problem	1	1
Packaging Problem	1	1
Device Emits Odor	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	14785	14785
No Patient Involvement	9852	9852
No Clinical Signs, Symptoms or Conditions	1805	1805
Skin Irritation	318	318
Tissue Damage	298	298
Tissue Breakdown	271	271
Blood Loss	230	230
Hemorrhage/Bleeding	180	180
Laceration(s)	148	148
Erythema	138	138
Skin Inflammation/ Irritation	131	131
Pain	128	128
Discomfort	96	96
Itching Sensation	46	46
Obstruction/Occlusion	40	40
Rash	37	37
Distress	30	30
Fungal Infection	26	26
Blister	26	26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Cramp(s) /Muscle Spasm(s)	20	20
No Known Impact Or Consequence To Patient	18	18
Abrasion	17	17
Skin Tears	13	13
Unspecified Infection	12	12
Ulcer	12	12
Hypersensitivity/Allergic reaction	10	10
Fluid Discharge	10	10
Urinary Tract Infection	9	9
Skin Infection	8	8
Bacterial Infection	8	8
Burning Sensation	8	8
Necrosis	7	7
Anxiety	7	7
Bruise/Contusion	6	6
Urinary Retention	6	6
Burn(s)	6	6
Injury	6	6
Cellulitis	5	5
Swelling/ Edema	5	5
Pressure Sores	5	5
Reaction	4	4
Inflammation	4	4
Irritation	3	3
Skin Discoloration	3	3
Purulent Discharge	3	3
Abdominal Distention	2	2
Peeling	2	2
Contact Dermatitis	2	2
Discharge	2	2