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	287	288
Insufficient Information	267	268
Inadequacy of Device Shape and/or Size	77	78
Mechanical Problem	66	66
Defective Device	62	62
Migration	58	59
Fracture	38	38
Malposition of Device	35	35
Appropriate Term/Code Not Available	10	10
Device Appears to Trigger Rejection	9	9
Break	8	8
Material Puncture/Hole	8	8
Nonstandard Device	7	7
Positioning Problem	6	6
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	424	425
Unspecified Infection	129	129
Pain	113	114
Erosion	94	94
Discomfort	56	56
Insufficient Information	48	48
Perforation	42	42
Deformity/ Disfigurement	24	24
Bacterial Infection	17	18
Unspecified Tissue Injury	13	13
Swelling/ Edema	13	13
Failure of Implant	12	12
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
Fluid Discharge	4	4
Fever	4	4
Urinary Retention	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Skin Inflammation/ Irritation	3	3
Erythema	3	3
Numbness	3	3
Sexual Dysfunction	2	2
Hemorrhage/Bleeding	2	2
Abscess	2	2
Unspecified Kidney or Urinary Problem	2	2
Scar Tissue	2	2
Nerve Damage	2	2
Cellulitis	2	2
Hypersensitivity/Allergic reaction	2	2
Seroma	1	1
Erectile Dysfunction	1	1
Dyspareunia	1	1
Depression	1	1
Rash	1	1
Injury	1	1
Foreign Body Reaction	1	1
Ecchymosis	1	1
Cardiac Arrest	1	1
Post Operative Wound Infection	1	1
Rupture	1	1
Urethral Stenosis/Stricture	1	1
Localized Skin Lesion	1	1
Ulcer	1	1
Myocardial Infarction	1	1