TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	22	22
Detachment of Device or Device Component	18	18
Melted	10	10
Break	10	10
Material Integrity Problem	8	8
Temperature Problem	6	6
Smoking	6	6
Fracture	6	6
Material Separation	5	5
Excessive Heating	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Thermal Decomposition of Device	4	4
Device Emits Odor	3	3
Physical Resistance/Sticking	3	3
Device Fell	2	2
Material Discolored	2	2
Disconnection	2	2
Difficult to Remove	2	2
Material Fragmentation	2	2
Difficult to Insert	1	1
Leak/Splash	1	1
Circuit Failure	1	1
Crack	1	1
Device Slipped	1	1
Fire	1	1
Appropriate Term/Code Not Available	1	1
Mechanical Jam	1	1
Device Dislodged or Dislocated	1	1
Material Deformation	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Device Damaged Prior to Use	1	1
Component Missing	1	1
Dull, Blunt	1	1
Defective Device	1	1
Sparking	1	1
Malposition of Device	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	40	40
No Consequences Or Impact To Patient	31	31
No Known Impact Or Consequence To Patient	9	9
No Patient Involvement	7	7
Superficial (First Degree) Burn	5	5
Burn, Thermal	5	5
Burn(s)	3	3
Endophthalmitis	2	2
Insufficient Information	2	2
Partial thickness (Second Degree) Burn	1	1
Device Embedded In Tissue or Plaque	1	1
Eye Pain	1	1
Inflammation	1	1
Blurred Vision	1	1
Patient Problem/Medical Problem	1	1
Discomfort	1	1
Injury	1	1