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	135	135
Excessive Heating	121	121
Adverse Event Without Identified Device or Use Problem	89	89
Insufficient Information	77	77
Product Quality Problem	72	72
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
Use of Device Problem	16	16
Sparking	15	15
Device Emits Odor	12	12
Thermal Decomposition of Device	12	12
Smoking	11	11
Fail-Safe Problem	11	11
Break	10	10
Material Twisted/Bent	8	8
Melted	8	8
Patient Device Interaction Problem	7	7
Patient-Device Incompatibility	6	6
Unexpected Therapeutic Results	5	5
Energy Output Problem	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Material Discolored	3	3
Failure to Shut Off	3	3
Protective Measures Problem	2	2
No Apparent Adverse Event	2	2
Naturally Worn	2	2
Noise, Audible	2	2
Lack of Maintenance Documentation or Guidelines	2	2
Electrical /Electronic Property Problem	2	2
Electrical Shorting	2	2
Material Puncture/Hole	2	2
Defective Device	2	2
Therapeutic or Diagnostic Output Failure	1	1
Unintended Electrical Shock	1	1
Unexpected Shutdown	1	1
Fail-Safe Did Not Operate	1	1
Key or Button Unresponsive/not Working	1	1
Material Frayed	1	1
Component Missing	1	1
Insufficient Heating	1	1
Electrical Power Problem	1	1
Device-Device Incompatibility	1	1
Detachment of Device or Device Component	1	1
Failure to Power Up	1	1
Device Remains Activated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	370	370
Insufficient Information	148	148
No Clinical Signs, Symptoms or Conditions	126	126
No Known Impact Or Consequence To Patient	31	31
Superficial (First Degree) Burn	23	23
Partial thickness (Second Degree) Burn	19	19
Full thickness (Third Degree) Burn	16	16
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
Dry Eye(s)	2	2
Unspecified Infection	2	2
Discomfort	2	2
Injury	2	2
Fluid Discharge	2	2
Skin Burning Sensation	2	2
Eye Pain	1	1
Convulsion/Seizure	1	1
No Information	1	1
Dizziness	1	1
Skin Discoloration	1	1
Nerve Damage	1	1
Itching Sensation	1	1
Irritation	1	1
Unspecified Tissue Injury	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Confusion/ Disorientation	1	1
Eye Burn	1	1
Diaphoresis	1	1
Inadequate Pain Relief	1	1
Impaired Healing	1	1
Myalgia	1	1
Hemorrhage/Bleeding	1	1
Erythema	1	1
Death	1	1