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	311	312
Insufficient Device Problem Information	289	290
Inadequacy of Device Shape and/or Size	87	88
Mechanical Problem	70	70
Defective Device	60	60
Migration	59	60
Fracture	40	40
Malposition of Device	37	37
Nonstandard Device	13	13
Appropriate Device Problem Term/Code Not Available	10	10
Device Appears to Trigger Rejection	9	9
Break	9	9
Material Puncture/Hole	7	7
Positioning Problem	6	6
Material Too Soft/Flexible	5	5
Material Deformation	4	4
No Apparent Adverse Event	4	4
Material Erosion	4	4
Device Dislodged or Dislocated	3	3
Noise, Audible	3	3
Use of Device Problem	3	3
Difficult to Insert	3	3
Material Protrusion/Extrusion	2	2
Patient Device Interaction Problem	2	2
Migration or Expulsion of Device	2	2
Off-Label Use	2	2
Patient-Device Incompatibility	1	1
Device Markings/Labelling Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Human-Device Interface Problem	1	1
Material Twisted/Bent	1	1
Unintended System Motion	1	1
Unsealed Device Packaging	1	1
Crack	1	1
Degraded	1	1
Material Discolored	1	1
Inflation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	473	474
Unspecified Infection	139	139
Pain	118	119
Erosion	106	106
Discomfort	58	58
Insufficient Information	48	48
Perforation	43	43
Deformity/ Disfigurement	29	29
Bacterial Infection	17	18
Swelling/ Edema	14	14
Unspecified Tissue Injury	13	13
Purulent Discharge	12	12
Failure of Implant	12	12
Necrosis	11	11
Wound Dehiscence	11	11
Inflammation	9	9
Skin Erosion	9	9
No Known Impact Or Consequence To Patient	7	7
Hematoma	7	7
Fever	6	6
Fluid Discharge	6	6
Fistula	5	5
Urinary Retention	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Erythema	4	4
Scar Tissue	3	3
Skin Inflammation/ Irritation	3	3
Numbness	3	3
Sexual Dysfunction	2	2
Hypersensitivity/Allergic reaction	2	2
Fibrosis	2	2
Nerve Damage	2	2
Cellulitis	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Unspecified Kidney or Urinary Problem	2	2
Abscess	2	2
Sensitivity of Teeth	1	1
Urinary Frequency / Polyuria	1	1
No Consequences Or Impact To Patient	1	1
Injury	1	1
Foreign Body Reaction	1	1
Myocardial Infarction	1	1
Impaired Healing	1	1
Fungal Infection	1	1
Urinary Incontinence	1	1
Dysuria	1	1
Ulcer	1	1
Depression	1	1
Localized Skin Lesion	1	1
Bruise/Contusion	1	1