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	16	16
Tear, Rip or Hole in Device Packaging	7	7
Temperature Problem	4	4
Use of Device Problem	2	2
Output Problem	2	2
Device Dislodged or Dislocated	2	2
Gas/Air Leak	1	1
Human-Device Interface Problem	1	1
Moisture or Humidity Problem	1	1
Scratched Material	1	1
Detachment of Device or Device Component	1	1
Break	1	1
Insufficient Cooling	1	1
Crack	1	1
Fluid/Blood Leak	1	1
Energy Output Problem	1	1
Material Separation	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Unexpected Therapeutic Results	1	1
No Apparent Adverse Event	1	1
Device Handling Problem	1	1
Activation Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	8	8
Cryogenic Burn	5	5
No Clinical Signs, Symptoms or Conditions	5	5
Nerve Damage	4	4
Inadequate Pain Relief	3	3
Pain	2	2
Burn(s)	2	2
No Known Impact Or Consequence To Patient	2	2
Partial thickness (Second Degree) Burn	1	1
No Information	1	1
Respiratory Insufficiency	1	1
Hypersensitivity/Allergic reaction	1	1
Decreased Sensitivity	1	1
Perforation	1	1
Pneumothorax	1	1
Visual Impairment	1	1
Injury	1	1
Perforation of Esophagus	1	1
Burn, Thermal	1	1
Electric Shock	1	1
Arrhythmia	1	1