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	147	147
Excessive Heating	121	121
Adverse Event Without Identified Device or Use Problem	90	90
Insufficient Information	85	85
Product Quality Problem	73	73
Improper or Incorrect Procedure or Method	49	49
Fire	43	43
Nonstandard Device	40	42
Overheating of Device	27	27
Temperature Problem	23	24
Appropriate Term/Code Not Available	20	20
Use of Device Problem	17	17
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
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
Scratched Material	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
Insufficient Heating	1	1
Unexpected Shutdown	1	2
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)	385	385
Insufficient Information	150	150
No Clinical Signs, Symptoms or Conditions	128	131
No Known Impact Or Consequence To Patient	31	31
Superficial (First Degree) Burn	23	23
Partial thickness (Second Degree) Burn	21	21
Full thickness (Third Degree) Burn	16	16
No Consequences Or Impact To Patient	14	14
Blister	11	11
Burn, Thermal	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Pain	7	7
Electric Shock	5	5
Rash	5	5
Skin Inflammation/ Irritation	4	4
Unspecified Infection	3	3
Undesired Nerve Stimulation	3	3
Scar Tissue	3	3
Skin Burning Sensation	2	2
Fluid Discharge	2	2
Discomfort	2	2
Injury	2	2
Dry Eye(s)	2	2
Impaired Healing	2	2
Irritation	1	1
Confusion/ Disorientation	1	1
Burning Sensation	1	1
Skin Discoloration	1	1
Erythema	1	1
Nerve Damage	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Eye Burn	1	1
Myalgia	1	1
Itching Sensation	1	1
No Information	1	1
Unspecified Tissue Injury	1	1
Dizziness	1	1
Convulsion/Seizure	1	1
Hemorrhage/Bleeding	1	1
Diaphoresis	1	1
Inadequate Pain Relief	1	1
Eye Pain	1	1
Death	1	1