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	76	76
Explosion	42	42
Material Rupture	16	16
Fluid/Blood Leak	9	9
Break	5	5
Leak/Splash	4	4
Temperature Problem	3	3
Activation Problem	3	3
Gel Leak	2	2
Overheating of Device	2	2
Activation Failure	2	2
Insufficient Heating	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Premature Activation	1	1
Material Puncture/Hole	1	1
Material Perforation	1	1
Component Missing	1	1
Defective Device	1	1
Activation, Positioning or Separation Problem	1	1
Appropriate Term/Code Not Available	1	1
Crack	1	1
Unexpected Therapeutic Results	1	1
Defective Component	1	1
Material Integrity Problem	1	1
Hole In Material	1	1
Material Separation	1	1
Device Handling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	60	60
No Consequences Or Impact To Patient	43	43
No Known Impact Or Consequence To Patient	25	25
Insufficient Information	13	13
Chemical Exposure	5	5
No Patient Involvement	3	3
Laceration(s)	2	2
Skin Irritation	2	2
No Information	2	2
Eye Burn	1	1
Burn(s)	1	1
Fluid Discharge	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Erythema	1	1
Burning Sensation	1	1
Injury	1	1
Burn, Thermal	1	1
Eye Injury	1	1