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	42
Material Rupture	20	20
Fluid/Blood Leak	7	7
Leak/Splash	5	5
Gel Leak	4	4
Temperature Problem	4	4
Break	3	3
Activation Problem	3	3
Device Difficult to Setup or Prepare	2	2
Activation, Positioning or Separation Problem	1	1
Material Puncture/Hole	1	1
Insufficient Information	1	1
Defective Component	1	1
Defective Device	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Device Handling Problem	1	1
Material Separation	1	1
Activation Failure	1	1
Appropriate Term/Code Not Available	1	1
Insufficient Heating	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	143	143
No Consequences Or Impact To Patient	37	37
Insufficient Information	15	15
No Known Impact Or Consequence To Patient	12	12
Chemical Exposure	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Skin Inflammation/ Irritation	2	2
Burn(s)	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
Eye Injury	1	1
Fluid Discharge	1	1