TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	40	40
Detachment of Device or Device Component	16	16
Break	8	8
Smoking	6	6
Excessive Heating	6	6
Material Integrity Problem	5	5
Use of Device Problem	5	5
Melted	4	4
Dull, Blunt	4	4
Thermal Decomposition of Device	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Disconnection	2	2
Device-Device Incompatibility	2	2
Physical Resistance/Sticking	2	2
Unintended Movement	2	2
Difficult to Remove	2	2
Material Protrusion/Extrusion	2	2
Temperature Problem	2	2
Material Frayed	1	1
Device Contaminated During Manufacture or Shipping	1	1
Mechanical Problem	1	1
Malposition of Device	1	1
Device Fell	1	1
Material Fragmentation	1	1
Shipping Damage or Problem	1	1
Material Discolored	1	1
Component Missing	1	1
Material Deformation	1	1
Optical Problem	1	1
Device Handling Problem	1	1
Device Emits Odor	1	1
Material Separation	1	1
Display or Visual Feedback Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Intermittent Loss of Power	1	1
Output below Specifications	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	85	85
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
Discomfort	2	2
Blurred Vision	2	2
Corneal Clouding/Hazing	1	1
High Blood Pressure/ Hypertension	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Red Eye(s)	1	1
Corneal Edema	1	1
Loss of Vision	1	1
Eye Pain	1	1