TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	282	283
Insufficient Information	262	263
Inadequacy of Device Shape and/or Size	75	76
Mechanical Problem	64	64
Defective Device	62	62
Migration	58	59
Fracture	37	37
Malposition of Device	35	35
Appropriate Term/Code Not Available	10	10
Break	8	8
Device Appears to Trigger Rejection	8	8
Material Puncture/Hole	7	7
Positioning Problem	6	6
Nonstandard Device	5	5
Material Too Soft/Flexible	5	5
Material Erosion	4	4
Material Deformation	4	4
Patient Device Interaction Problem	3	3
Difficult to Insert	3	3
Noise, Audible	3	3
Migration or Expulsion of Device	2	2
Off-Label Use	2	2
Therapeutic or Diagnostic Output Failure	2	2
Use of Device Problem	2	2
Material Protrusion/Extrusion	2	2
No Apparent Adverse Event	2	2
Device Dislodged or Dislocated	2	2
Crack	1	1
Device Markings/Labelling Problem	1	1
Patient-Device Incompatibility	1	1
Unsealed Device Packaging	1	1
Microbial Contamination of Device	1	1
Degraded	1	1
Material Discolored	1	1
Material Twisted/Bent	1	1
Inflation Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Unintended System Motion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	414	415
Unspecified Infection	126	126
Pain	112	113
Erosion	92	92
Discomfort	55	55
Insufficient Information	48	48
Perforation	41	41
Deformity/ Disfigurement	23	23
Bacterial Infection	17	18
Swelling/ Edema	13	13
Unspecified Tissue Injury	13	13
Failure of Implant	11	11
Necrosis	11	11
Purulent Discharge	11	11
Inflammation	9	9
Skin Erosion	9	9
Wound Dehiscence	8	8
Hematoma	7	7
No Known Impact Or Consequence To Patient	7	7
Fistula	5	5
Fever	4	4
Urinary Retention	4	4
Fluid Discharge	4	4
Skin Inflammation/ Irritation	3	3
Erythema	3	3
Numbness	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Cellulitis	2	2
Sexual Dysfunction	2	2
Hemorrhage/Bleeding	2	2
Hypersensitivity/Allergic reaction	2	2
Nerve Damage	2	2
Scar Tissue	2	2
Unspecified Kidney or Urinary Problem	2	2
Abscess	2	2
Urinary Tract Infection	1	1
Bruise/Contusion	1	1
Sensitivity of Teeth	1	1
Pocket Erosion	1	1
Fibrosis	1	1
Urinary Frequency	1	1
No Consequences Or Impact To Patient	1	1
Unspecified Heart Problem	1	1
Ulcer	1	1
Myocardial Infarction	1	1
Ecchymosis	1	1
Dyspareunia	1	1
Depression	1	1
Erectile Dysfunction	1	1
Injury	1	1