TPLC - Total Product Life Cycle

show TPLC since

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	179	179
Explosion	42	42
Material Rupture	29	29
Fluid/Blood Leak	15	15
Leak/Splash	13	13
Chemical Spillage	7	7
Break	7	7
Temperature Problem	5	5
Use of Device Problem	5	5
Overheating of Device	5	5
Gel Leak	4	4
Device Operates Differently Than Expected	4	4
Material Integrity Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Insufficient Information	3	3
Activation Problem	3	3
Activation Failure	2	2
Therapeutic or Diagnostic Output Failure	2	2
Extrusion	2	2
Device Difficult to Setup or Prepare	2	2
Insufficient Heating	2	2
Unsealed Device Packaging	2	2
Premature Activation	1	1
Device Emits Odor	1	1
Self-Activation or Keying	1	1
Material Separation	1	1
Unexpected Therapeutic Results	1	1
Device Inoperable	1	1
Hole In Material	1	1
Labelling, Instructions for Use or Training Problem	1	1
Material Fragmentation	1	1
Component Falling	1	1
Crack	1	1
Material Puncture/Hole	1	1
Product Quality Problem	1	1
Activation, Positioning or Separation Problem	1	1
Material Deformation	1	1
Expulsion	1	1
Improper or Incorrect Procedure or Method	1	1
Material Perforation	1	1
Defective Component	1	1
Component Missing	1	1
Tear, Rip or Hole in Device Packaging	1	1
Split	1	1
Defective Device	1	1
Patient-Device Incompatibility	1	1
Appropriate Term/Code Not Available	1	1
Device Handling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	129	129
No Consequences Or Impact To Patient	50	50
No Known Impact Or Consequence To Patient	40	40
Chemical Exposure	22	22
Insufficient Information	13	13
No Information	9	9
Burn(s)	8	8
Eye Injury	6	7
Foreign Body In Patient	5	5
No Patient Involvement	4	4
Injury	4	4
Burn, Thermal	3	3
Discomfort	3	3
Burning Sensation	3	3
Skin Irritation	3	3
Partial thickness (Second Degree) Burn	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Code Available	2	2
Skin Inflammation/ Irritation	2	2
Corneal Abrasion	2	2
Irritation	2	2
Itching Sensation	2	2
Laceration(s)	2	2
Respiratory Distress	1	1
Erythema	1	1
Blurred Vision	1	1
Exposure to Body Fluids	1	1
Complaint, Ill-Defined	1	1
Caustic/Chemical Burns	1	1
Eye Burn	1	1
Superficial (First Degree) Burn	1	1
Fluid Discharge	1	1