TPLC - Total Product Life Cycle

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Device	infant heel warmer (chemical heat pack)
Product Code	MPO
Regulation Number	890.5710
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	134	134
Explosion	42	42
Material Rupture	20	20
Fluid/Blood Leak	10	10
Leak/Splash	6	6
Gel Leak	4	4
Temperature Problem	4	4
Break	4	4
Activation Problem	3	3
Activation Failure	2	2
Device Difficult to Setup or Prepare	2	2
Material Puncture/Hole	1	1
Overheating of Device	1	1
Insufficient Heating	1	1
Appropriate Term/Code Not Available	1	1
Device Handling Problem	1	1
Material Separation	1	1
Unexpected Therapeutic Results	1	1
Defective Component	1	1
Defective Device	1	1
Activation, Positioning or Separation Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	129	129
No Consequences Or Impact To Patient	40	40
No Known Impact Or Consequence To Patient	16	16
Insufficient Information	13	13
Chemical Exposure	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Information	2	2
Skin Inflammation/ Irritation	2	2
Discomfort	2	2
Laceration(s)	2	2
Skin Irritation	1	1
Eye Burn	1	1
Burn(s)	1	1
Corneal Abrasion	1	1
Erythema	1	1
Eye Injury	1	1
Fluid Discharge	1	1