TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Malposition of Device	29059	29059
Positioning Problem	1899	1899
Adverse Event Without Identified Device or Use Problem	1164	1164
Fluid/Blood Leak	752	752
Human-Device Interface Problem	290	290
Material Too Rigid or Stiff	186	186
Material Disintegration	177	177
Difficult to Remove	152	152
Sharp Edges	94	94
Leak/Splash	61	61
Material Erosion	53	53
Increased Sensitivity	51	51
Material Separation	43	43
Device Handling Problem	42	42
Device Operates Differently Than Expected	39	39
Complete Blockage	27	27
Melted	27	27
Insufficient Information	24	24
Material Split, Cut or Torn	21	21
Partial Blockage	21	21
Sticking	19	19
Improper or Incorrect Procedure or Method	18	18
Failure To Adhere Or Bond	16	16
Material Protrusion/Extrusion	15	15
Physical Resistance/Sticking	14	14
Activation, Positioning or Separation Problem	13	13
Separation Problem	13	13
Material Too Soft/Flexible	10	10
Off-Label Use	9	9
Flare or Flash	9	9
Material Fragmentation	9	9
Defective Device	9	9
Appropriate Term/Code Not Available	7	7
Patient-Device Incompatibility	6	6
Device Abrasion From Instrument Or Another Object	6	6
Obstruction of Flow	5	5
Use of Device Problem	5	5
Material Integrity Problem	5	5
Material Deformation	4	4
Material Discolored	4	4
Device Contamination with Chemical or Other Material	4	4
Delamination	4	4
Inadequacy of Device Shape and/or Size	4	4
Missing Value Reason	3	3
Product Quality Problem	3	3
Wrinkled	3	3
Material Puncture/Hole	3	3
Difficult To Position	3	3
Expulsion	2	2
Migration or Expulsion of Device	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	15686	15686
No Patient Involvement	10942	10942
No Clinical Signs, Symptoms or Conditions	1807	1807
Skin Irritation	681	681
Tissue Damage	578	578
Rash	509	509
Itching Sensation	413	413
Blood Loss	352	352
Erythema	307	307
Tissue Breakdown	288	288
Skin Discoloration	281	281
Hemorrhage/Bleeding	209	209
No Known Impact Or Consequence To Patient	191	191
Pain	185	185
Laceration(s)	172	172
Skin Inflammation/ Irritation	131	131
Skin Inflammation	120	120
Irritation	119	119
Discomfort	107	107
Fungal Infection	97	97
Skin Tears	75	75
Fluid Discharge	70	70
Burning Sensation	64	64
Skin Erosion	47	47
No Code Available	43	43
Obstruction/Occlusion	42	42
Inflammation	41	41
Discharge	41	41
Abrasion	39	39
Ulcer	37	37
Distress	30	30
Hypersensitivity/Allergic reaction	28	28
Local Reaction	27	27
Ulceration	26	26
Blister	26	26
Unspecified Infection	25	25
Pressure Sores	21	21
Reaction	20	20
Cramp(s) /Muscle Spasm(s)	20	20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Increased Sensitivity	18	18
Cellulitis	16	16
Peeling	14	14
Urticaria	14	14
Abnormal Blood Gases	13	13
Urinary Tract Infection	13	13
Bacterial Infection	11	11
Wheal(s)	10	10
Injury	8	8
Skin Infection	8	8