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	140	140
Explosion	43	43
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
Device Difficult to Setup or Prepare	2	2
Activation Failure	2	2
Material Puncture/Hole	1	1
Insufficient Information	1	1
Defective Component	1	1
Defective Device	1	1
Appropriate Term/Code Not Available	1	1
Unexpected Therapeutic Results	1	1
Insufficient Heating	1	1
Activation, Positioning or Separation Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Device Handling Problem	1	1
Material Separation	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	139	139
No Consequences Or Impact To Patient	40	40
No Known Impact Or Consequence To Patient	16	16
Insufficient Information	14	14
Chemical Exposure	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Information	2	2
Skin Inflammation/ Irritation	2	2
Burn(s)	2	2
Discomfort	2	2
Laceration(s)	2	2
Skin Irritation	1	1
Corneal Abrasion	1	1
Eye Burn	1	1
Erythema	1	1
Unspecified Eye / Vision Problem	1	1
Eye Injury	1	1
Fluid Discharge	1	1