TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Malposition of Device	1047	1047
Adverse Event Without Identified Device or Use Problem	293	293
Sharp Edges	96	96
Material Too Rigid or Stiff	79	79
Positioning Problem	78	78
Difficult to Remove	64	64
Human-Device Interface Problem	55	55
Fluid/Blood Leak	43	43
Appropriate Term/Code Not Available	22	22
Product Quality Problem	13	13
Leak/Splash	13	13
Device Operates Differently Than Expected	12	12
Defective Device	11	11
Insufficient Information	11	11
Sticking	10	10
Material Disintegration	6	6
Failure To Adhere Or Bond	5	5
Device Handling Problem	5	5
Device Markings/Labelling Problem	5	5
Material Too Soft/Flexible	4	4
Material Protrusion/Extrusion	4	4
Increased Sensitivity	4	4
Obstruction of Flow	4	4
Loss of or Failure to Bond	3	3
Incomplete or Missing Packaging	3	3
Material Deformation	3	3
Device Contamination with Chemical or Other Material	2	2
Off-Label Use	2	2
Nonstandard Device	2	2
Packaging Problem	2	2
Scratched Material	2	2
Delamination	2	2
Use of Device Problem	2	2
Activation Failure	2	2
Material Integrity Problem	2	2
Inflation Problem	2	2
Burst Container or Vessel	1	1
Gas/Air Leak	1	1
Patient-Device Incompatibility	1	1
Defective Component	1	1
Improper or Incorrect Procedure or Method	1	1
Misassembled	1	1
Occlusion Within Device	1	1
Component Missing	1	1
Material Puncture/Hole	1	1
Deflation Problem	1	1
Melted	1	1
Material Erosion	1	1
Material Rupture	1	1
Dull, Blunt	1	1
Noise, Audible	1	1
Break	1	1
Temperature Problem	1	1
Detachment of Device or Device Component	1	1
Crack	1	1
Inadequacy of Device Shape and/or Size	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	747	747
No Clinical Signs, Symptoms or Conditions	166	166
No Patient Involvement	147	147
Skin Irritation	145	145
Rash	116	116
Tissue Damage	112	112
Itching Sensation	98	98
No Known Impact Or Consequence To Patient	76	76
Skin Discoloration	72	72
Pain	51	51
Skin Inflammation/ Irritation	48	48
Erythema	47	47
Hemorrhage/Bleeding	39	39
Blood Loss	38	38
Distress	32	32
Skin Inflammation	23	23
Abrasion	22	22
Irritation	21	21
Fungal Infection	21	21
Burning Sensation	17	17
Fluid Discharge	14	14
Hypersensitivity/Allergic reaction	14	14
Skin Tears	13	13
Tissue Breakdown	10	10
Laceration(s)	10	10
Urinary Tract Infection	9	9
Discharge	9	9
Ulcer	9	9
Blister	9	9
No Code Available	8	8
Reaction	8	8
Inflammation	8	8
Skin Erosion	7	7
Bacterial Infection	6	6
Discomfort	6	6
Unspecified Infection	4	4
Fungus	3	3
Cellulitis	3	3
Purulent Discharge	3	3
Urticaria	3	3
Pressure Sores	3	3
Increased Sensitivity	3	3
Wheal(s)	2	2
Skin Infection	2	2
Aspiration/Inhalation	2	2
Granuloma	2	2
Ulceration	2	2
Foreign Body Reaction	2	2
Pneumonia	2	2
Peeling	1	1
Necrosis	1	1
Swelling	1	1
Local Reaction	1	1
Fainting	1	1
Hyperplasia	1	1
Wound Dehiscence	1	1
Abscess	1	1
Emotional Changes	1	1
Contact Dermatitis	1	1
Drug Resistant Bacterial Infection	1	1
No Information	1	1
Visual Disturbances	1	1