TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	123	123
Excessive Heating	119	119
Improper or Incorrect Procedure or Method	109	109
Labelling, Instructions for Use or Training Problem	100	100
Insufficient Information	76	76
Fire	70	70
Product Quality Problem	68	68
Sparking	51	51
Overheating of Device	45	45
Nonstandard Device	40	40
Smoking	39	39
Thermal Decomposition of Device	36	36
Break	28	28
Temperature Problem	28	28
Use of Device Problem	24	24
Appropriate Term/Code Not Available	22	22
Material Split, Cut or Torn	17	17
Material Twisted/Bent	14	14
Melted	14	14
Device Emits Odor	13	13
Fail-Safe Problem	11	11
Noise, Audible	11	11
Failure to Shut Off	10	10
Patient-Device Incompatibility	8	8
Patient Device Interaction Problem	7	7
Electrical Shorting	6	6
Material Puncture/Hole	6	6
Naturally Worn	6	6
Unexpected Therapeutic Results	5	5
Material Discolored	5	5
Energy Output Problem	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Protective Measures Problem	3	3
Defective Device	2	2
Therapeutic or Diagnostic Output Failure	2	2
No Apparent Adverse Event	2	2
Material Protrusion/Extrusion	2	2
Detachment of Device or Device Component	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Deformation Due to Compressive Stress	2	2
Electrical /Electronic Property Problem	2	2
Lack of Maintenance Documentation or Guidelines	2	2
Flare or Flash	2	2
Failure to Power Up	2	2
Component Missing	2	2
Self-Activation or Keying	2	2
Loose or Intermittent Connection	1	1
Arcing	1	1
Device Remains Activated	1	1
Loss of Power	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	382	382
Insufficient Information	137	137
No Clinical Signs, Symptoms or Conditions	116	116
No Known Impact Or Consequence To Patient	105	105
No Consequences Or Impact To Patient	63	63
Burn, Thermal	26	26
Partial thickness (Second Degree) Burn	25	25
Superficial (First Degree) Burn	23	23
Full thickness (Third Degree) Burn	16	16
Electric Shock	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Blister	7	7
Pain	5	5
Rash	5	5
Skin Inflammation/ Irritation	4	4
Undesired Nerve Stimulation	3	3
Scar Tissue	3	3
Injury	3	3
No Information	3	3
Dry Eye(s)	2	2
Discomfort	2	2
Shock	2	2
Death	2	2
Unspecified Infection	2	2
Skin Burning Sensation	2	2
Confusion/ Disorientation	1	1
Myalgia	1	1
Itching Sensation	1	1
Irritation	1	1
Dizziness	1	1
Erythema	1	1
Nerve Damage	1	1
Swelling	1	1
Diaphoresis	1	1
Peeling	1	1
Fluid Discharge	1	1
Tingling	1	1
Unspecified Tissue Injury	1	1
Convulsion/Seizure	1	1
Impaired Healing	1	1
Hemorrhage/Bleeding	1	1
Inadequate Pain Relief	1	1
Eye Pain	1	1