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	137	137
Explosion	42	43
Material Rupture	22	22
Fluid/Blood Leak	7	7
Temperature Problem	7	7
Leak/Splash	5	5
Gel Leak	4	4
Break	3	3
Activation Problem	3	3
Defective Device	3	3
Insufficient Heating	3	3
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
Adverse Event Without Identified Device or Use Problem	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	149	149
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
Burn(s)	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Skin Inflammation/ Irritation	2	2
Discomfort	2	2
Laceration(s)	2	2
Skin Irritation	1	1
Corneal Abrasion	1	1
No Information	1	1
Eye Burn	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