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	185	185
Explosion	43	43
Material Rupture	29	29
Fluid/Blood Leak	15	15
Leak/Splash	13	13
Break	7	7
Chemical Spillage	7	7
Temperature Problem	5	5
Overheating of Device	5	5
Use of Device Problem	5	5
Insufficient Information	4	4
Gel Leak	4	4
Device Operates Differently Than Expected	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Material Integrity Problem	3	3
Activation Problem	3	3
Activation Failure	2	2
Insufficient Heating	2	2
Device Difficult to Setup or Prepare	2	2
Therapeutic or Diagnostic Output Failure	2	2
Extrusion	2	2
Unsealed Device Packaging	2	2
Material Separation	1	1
Labelling, Instructions for Use or Training Problem	1	1
Device Emits Odor	1	1
Tear, Rip or Hole in Device Packaging	1	1
Appropriate Term/Code Not Available	1	1
Product Quality Problem	1	1
Unexpected Therapeutic Results	1	1
Device Inoperable	1	1
Self-Activation or Keying	1	1
Improper or Incorrect Procedure or Method	1	1
Component Missing	1	1
Material Puncture/Hole	1	1
Hole In Material	1	1
Component Falling	1	1
Premature Activation	1	1
Patient-Device Incompatibility	1	1
Split	1	1
Crack	1	1
Expulsion	1	1
Material Deformation	1	1
Device Handling Problem	1	1
Defective Device	1	1
Defective Component	1	1
Material Fragmentation	1	1
Material Perforation	1	1
Activation, Positioning or Separation Problem	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	50	50
No Known Impact Or Consequence To Patient	40	40
Chemical Exposure	26	26
Insufficient Information	14	14
No Information	9	9
Burn(s)	9	9
Eye Injury	6	7
Foreign Body In Patient	5	5
Injury	4	4
No Patient Involvement	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Skin Irritation	3	3
Burn, Thermal	3	3
Burning Sensation	3	3
Discomfort	3	3
Partial thickness (Second Degree) Burn	3	3
No Code Available	2	2
Corneal Abrasion	2	2
Skin Inflammation/ Irritation	2	2
Itching Sensation	2	2
Irritation	2	2
Laceration(s)	2	2
Superficial (First Degree) Burn	1	1
Complaint, Ill-Defined	1	1
Respiratory Distress	1	1
Eye Burn	1	1
Exposure to Body Fluids	1	1
Erythema	1	1
Unspecified Eye / Vision Problem	1	1
Fluid Discharge	1	1
Caustic/Chemical Burns	1	1
Blurred Vision	1	1