TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	37	37
Detachment of Device or Device Component	20	20
Break	10	10
Smoking	5	5
Use of Device Problem	5	5
Dull, Blunt	5	5
Excessive Heating	5	5
Material Integrity Problem	4	4
Melted	3	3
Display or Visual Feedback Problem	3	3
Device-Device Incompatibility	3	3
Difficult to Remove	2	2
Thermal Decomposition of Device	2	2
Disconnection	2	2
Material Frayed	2	2
Material Protrusion/Extrusion	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Temperature Problem	2	2
Unintended Movement	2	2
Physical Resistance/Sticking	2	2
Mechanical Problem	1	1
Material Separation	1	1
Device Damaged Prior to Receipt by User	1	1
Improper or Incorrect Procedure or Method	1	1
Component Missing	1	1
Malposition of Device	1	1
Material Fragmentation	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Deformation	1	1
Optical Problem	1	1
Output below Specifications	1	1
Device Handling Problem	1	1
Intermittent Loss of Power	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	93	93
Insufficient Information	9	9
Superficial (First Degree) Burn	5	5
Burn(s)	4	4
Endophthalmitis	3	3
Partial thickness (Second Degree) Burn	3	3
Inflammation	2	2
Blurred Vision	2	2
Discomfort	2	2
Corneal Clouding/Hazing	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Red Eye(s)	1	1
High Blood Pressure/ Hypertension	1	1
Eye Pain	1	1
Loss of Vision	1	1
Corneal Edema	1	1
Foreign Body In Patient	1	1