TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Labelling, Instructions for Use or Training Problem	125	125
Excessive Heating	120	120
Adverse Event Without Identified Device or Use Problem	89	89
Insufficient Information	74	74
Product Quality Problem	71	71
Improper or Incorrect Procedure or Method	49	49
Fire	43	43
Nonstandard Device	40	40
Overheating of Device	25	25
Temperature Problem	23	23
Appropriate Term/Code Not Available	20	20
Sparking	15	15
Use of Device Problem	14	14
Device Emits Odor	11	11
Smoking	11	11
Thermal Decomposition of Device	11	11
Fail-Safe Problem	11	11
Break	10	10
Melted	8	8
Material Twisted/Bent	8	8
Patient Device Interaction Problem	7	7
Patient-Device Incompatibility	6	6
Unexpected Therapeutic Results	5	5
Energy Output Problem	4	4
Material Discolored	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Failure to Shut Off	3	3
Defective Device	2	2
Material Puncture/Hole	2	2
Electrical Shorting	2	2
No Apparent Adverse Event	2	2
Protective Measures Problem	2	2
Naturally Worn	2	2
Lack of Maintenance Documentation or Guidelines	2	2
Electrical /Electronic Property Problem	2	2
Noise, Audible	2	2
Key or Button Unresponsive/not Working	1	1
Failure to Power Up	1	1
Therapeutic or Diagnostic Output Failure	1	1
Component Missing	1	1
Fail-Safe Did Not Operate	1	1
Detachment of Device or Device Component	1	1
Unintended Electrical Shock	1	1
Electrical Power Problem	1	1
Unexpected Shutdown	1	1
Device-Device Incompatibility	1	1
Device Remains Activated	1	1
Material Frayed	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	361	361
Insufficient Information	143	143
No Clinical Signs, Symptoms or Conditions	124	124
No Known Impact Or Consequence To Patient	31	31
Superficial (First Degree) Burn	22	22
Partial thickness (Second Degree) Burn	18	18
Full thickness (Third Degree) Burn	15	15
No Consequences Or Impact To Patient	14	14
Burn, Thermal	9	9
Blister	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Pain	6	6
Electric Shock	5	5
Rash	5	5
Skin Inflammation/ Irritation	4	4
Scar Tissue	3	3
Undesired Nerve Stimulation	3	3
Unspecified Infection	2	2
Dry Eye(s)	2	2
Injury	2	2
Discomfort	2	2
Fluid Discharge	2	2
Skin Burning Sensation	2	2
Impaired Healing	1	1
Death	1	1
Diaphoresis	1	1
Dizziness	1	1
No Information	1	1
Itching Sensation	1	1
Myalgia	1	1
Skin Discoloration	1	1
Confusion/ Disorientation	1	1
Irritation	1	1
Erythema	1	1
Nerve Damage	1	1
Unspecified Tissue Injury	1	1
Convulsion/Seizure	1	1
Hemorrhage/Bleeding	1	1
Inadequate Pain Relief	1	1
Eye Pain	1	1