TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Labelling, Instructions for Use or Training Problem	163	163
Excessive Heating	120	120
Insufficient Information	89	89
Product Quality Problem	73	73
Adverse Event Without Identified Device or Use Problem	65	65
Overheating of Device	50	50
Nonstandard Device	42	44
Temperature Problem	35	36
Fire	31	31
Improper or Incorrect Procedure or Method	30	30
Appropriate Term/Code Not Available	20	20
Use of Device Problem	15	15
Thermal Decomposition of Device	14	14
Device Emits Odor	12	12
Fail-Safe Problem	11	11
Smoking	10	10
Patient Device Interaction Problem	9	9
Melted	9	9
Sparking	6	6
Unexpected Therapeutic Results	5	5
Patient-Device Incompatibility	4	4
Energy Output Problem	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Material Puncture/Hole	3	3
Defective Device	2	2
Material Discolored	2	2
Unintended Electrical Shock	2	2
No Apparent Adverse Event	2	2
Protective Measures Problem	2	2
Failure to Shut Off	2	2
Lack of Maintenance Documentation or Guidelines	2	2
Electrical /Electronic Property Problem	2	2
Noise, Audible	2	2
Therapeutic or Diagnostic Output Failure	1	1
Scratched Material	1	1
Key or Button Unresponsive/not Working	1	1
Failure to Power Up	1	1
Material Twisted/Bent	1	1
Fail-Safe Did Not Operate	1	1
Electrical Shorting	1	1
Material Protrusion/Extrusion	1	1
Electrical Power Problem	1	1
Unexpected Shutdown	1	2
Insufficient Heating	1	1
Device-Device Incompatibility	1	1
Material Frayed	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	363	363
Insufficient Information	169	169
No Clinical Signs, Symptoms or Conditions	140	143
Superficial (First Degree) Burn	34	34
Partial thickness (Second Degree) Burn	30	30
Full thickness (Third Degree) Burn	17	17
Blister	15	15
Pain	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Electric Shock	5	5
Rash	5	5
Scar Tissue	5	5
Skin Inflammation/ Irritation	4	4
Unspecified Tissue Injury	4	4
Unspecified Infection	3	3
Impaired Healing	3	3
Burn, Thermal	3	3
Erythema	3	3
Undesired Nerve Stimulation	3	3
Dry Eye(s)	2	2
Discomfort	2	2
Fluid Discharge	2	2
Skin Burning Sensation	2	2
Nausea	1	1
Diaphoresis	1	1
Dizziness	1	1
Itching Sensation	1	1
Myalgia	1	1
Eye Burn	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Skin Discoloration	1	1
Confusion/ Disorientation	1	1
Fever	1	1
Burning Sensation	1	1
Nerve Damage	1	1
Convulsion/Seizure	1	1
Hemorrhage/Bleeding	1	1
Inadequate Pain Relief	1	1
Eye Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	EYE COMFORT CARE LLC	II	Aug-14-2024
2	Navajo Manufacturing Company	I	Mar-21-2026
3	Whele LLC DBA Perch	I	Nov-23-2022