TPLC - Total Product Life Cycle

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Device	infant heel warmer (chemical heat pack)
Regulation Description	Hot or cold disposable 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	135	135
Material Rupture	13	13
Explosion	8	9
Temperature Problem	8	8
Leak/Splash	6	6
Gel Leak	4	4
Fluid/Blood Leak	4	4
Defective Device	3	3
Insufficient Heating	3	3
Break	2	2
Activation Problem	2	2
Device Difficult to Setup or Prepare	2	2
Use of Device Problem	2	2
Activation Failure	2	2
Activation, Positioning or Separation Problem	1	1
Crack	1	1
Material Puncture/Hole	1	1
Insufficient Information	1	1
Defective Component	1	1
Device Handling Problem	1	1
Material Separation	1	1
Appropriate Term/Code Not Available	1	1
Excessive Heating	1	1
Unexpected Therapeutic Results	1	1
Premature Activation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	154	154
Insufficient Information	17	18
Chemical Exposure	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Burn(s)	3	3
Skin Inflammation/ Irritation	2	2
Discomfort	2	2
Laceration(s)	2	2
Corneal Abrasion	1	1
Local Reaction	1	1
Eye Burn	1	1
Rash	1	1
Erythema	1	1
Unspecified Eye / Vision Problem	1	1
Hypothermia	1	1
Fluid Discharge	1	1
Caustic/Chemical Burns	1	1
Full thickness (Third Degree) Burn	1	1