TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Patient Device Interaction Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Pressure Problem	1	1
Break	1	1
Mechanical Problem	1	1
Malposition of Device	1	1
Insufficient Information	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Positioning Problem	1	1
Scratched Material	1	1
Use of Device Problem	1	1
Structural Problem	1	1
Device Dislodged or Dislocated	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6	6
Pressure Sores	5	5
Swelling/ Edema	2	2
Ulcer	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Urticaria	1	1
Hypersensitivity/Allergic reaction	1	1
Respiratory Arrest	1	1
Skin Inflammation/ Irritation	1	1
Aspiration/Inhalation	1	1
Anaphylactoid	1	1
Irritation	1	1
Injury	1	1
Neck Pain	1	1
Skin Erosion	1	1
Loss of Range of Motion	1	1
Insufficient Information	1	1
Pneumonia	1	1
Unspecified Tissue Injury	1	1
Respiratory Failure	1	1
Pulmonary Embolism	1	1