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	140	140
Explosion	43	44
Material Rupture	22	22
Temperature Problem	7	7
Fluid/Blood Leak	7	7
Leak/Splash	5	5
Gel Leak	4	4
Defective Device	3	3
Activation Problem	3	3
Break	3	3
Insufficient Heating	3	3
Activation Failure	2	2
Use of Device Problem	2	2
Device Difficult to Setup or Prepare	2	2
Activation, Positioning or Separation Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Device Handling Problem	1	1
Excessive Heating	1	1
Material Separation	1	1
Unexpected Therapeutic Results	1	1
Defective Component	1	1
Crack	1	1
Premature Activation	1	1
Material Puncture/Hole	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	151	151
No Consequences Or Impact To Patient	37	37
Insufficient Information	16	17
No Known Impact Or Consequence To Patient	12	12
Chemical Exposure	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Burn(s)	4	4
Skin Inflammation/ Irritation	2	2
Discomfort	2	2
Laceration(s)	2	2
Skin Irritation	1	1
No Information	1	1
Corneal Abrasion	1	1
Eye Burn	1	1
Local Reaction	1	1
Rash	1	1
Erythema	1	1
Unspecified Eye / Vision Problem	1	1
Hypothermia	1	1
Eye Injury	1	1
Fluid Discharge	1	1
Caustic/Chemical Burns	1	1
Full thickness (Third Degree) Burn	1	1