TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	319	320
Adverse Event Without Identified Device or Use Problem	316	317
Inadequacy of Device Shape and/or Size	88	89
Mechanical Problem	79	79
Migration	68	69
Defective Device	65	65
Fracture	39	39
Malposition of Device	36	36
Break	15	15
Appropriate Term/Code Not Available	10	10
Material Puncture/Hole	9	9
Device Appears to Trigger Rejection	8	8
Positioning Problem	7	7
Material Too Soft/Flexible	5	5
Material Erosion	5	5
Fluid/Blood Leak	4	4
Material Deformation	4	4
Noise, Audible	3	3
No Apparent Adverse Event	3	3
Use of Device Problem	3	3
Difficult to Insert	3	3
Patient Device Interaction Problem	3	3
Device Contamination with Chemical or Other Material	2	2
Material Protrusion/Extrusion	2	2
Therapeutic or Diagnostic Output Failure	2	2
Device Dislodged or Dislocated	2	2
Nonstandard Device	2	2
Off-Label Use	2	2
Migration or Expulsion of Device	2	2
Degraded	1	1
Material Discolored	1	1
Material Too Rigid or Stiff	1	1
Component Missing	1	1
Material Twisted/Bent	1	1
Inflation Problem	1	1
Microbial Contamination of Device	1	1
Unsealed Device Packaging	1	1
Detachment of Device or Device Component	1	1
Missing Information	1	1
Patient-Device Incompatibility	1	1
Device Markings/Labelling Problem	1	1
Peeled/Delaminated	1	1
Unintended System Motion	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	404	405
Unspecified Infection	144	144
Pain	129	130
Erosion	111	111
No Known Impact Or Consequence To Patient	75	75
Discomfort	61	61
Perforation	57	57
Insufficient Information	45	45
Deformity/ Disfigurement	24	24
Bacterial Infection	19	20
No Consequences Or Impact To Patient	14	14
Purulent Discharge	14	14
Failure of Implant	13	13
Swelling/ Edema	13	13
Necrosis	12	12
Unspecified Tissue Injury	12	12
Inflammation	12	12
Wound Dehiscence	9	9
Hematoma	9	9
Skin Erosion	9	9
No Information	6	6
Fistula	5	5
Fluid Discharge	5	5
Scarring	4	4
Numbness	4	4
Urinary Retention	4	4
Fever	4	4
Tissue Damage	3	3
Abscess	3	3
Erythema	3	3
Skin Inflammation/ Irritation	3	3
Hypersensitivity/Allergic reaction	2	2
Pocket Erosion	2	2
Nerve Damage	2	2
Post Operative Wound Infection	2	2
Cellulitis	2	2
Depression	2	2
Sexual Dysfunction	2	2
No Patient Involvement	2	2
Hemorrhage/Bleeding	2	2
Scar Tissue	2	2
Unspecified Kidney or Urinary Problem	2	2
Edema	2	2
Urinary Tract Infection	1	1
Bruise/Contusion	1	1
Sensitivity of Teeth	1	1
Fibrosis	1	1
Urinary Frequency	1	1
Sweating	1	1
Emotional Changes	1	1