TPLC - Total Product Life Cycle

show TPLC since

Device Problems	MDRs with this Device Problem	Events in those MDRs
Labelling, Instructions for Use or Training Problem	157	157
Excessive Heating	120	120
Insufficient Information	88	88
Product Quality Problem	73	73
Adverse Event Without Identified Device or Use Problem	64	64
Overheating of Device	47	47
Nonstandard Device	42	44
Fire	31	31
Temperature Problem	31	32
Improper or Incorrect Procedure or Method	29	29
Appropriate Term/Code Not Available	20	20
Use of Device Problem	15	15
Thermal Decomposition of Device	13	13
Device Emits Odor	12	12
Fail-Safe Problem	11	11
Patient Device Interaction Problem	9	9
Melted	9	9
Smoking	9	9
Sparking	6	6
Unexpected Therapeutic Results	5	5
Energy Output Problem	4	4
Patient-Device Incompatibility	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Material Puncture/Hole	3	3
Defective Device	2	2
Material Discolored	2	2
Electrical /Electronic Property Problem	2	2
Failure to Shut Off	2	2
Lack of Maintenance Documentation or Guidelines	2	2
Unintended Electrical Shock	2	2
Noise, Audible	2	2
Protective Measures Problem	2	2
No Apparent Adverse Event	2	2
Fail-Safe Did Not Operate	1	1
Key or Button Unresponsive/not Working	1	1
Scratched Material	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unexpected Shutdown	1	2
Material Protrusion/Extrusion	1	1
Material Twisted/Bent	1	1
Device-Device Incompatibility	1	1
Electrical Power Problem	1	1
Electrical Shorting	1	1
Material Frayed	1	1
Insufficient Heating	1	1
Failure to Power Up	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	356	356
Insufficient Information	164	164
No Clinical Signs, Symptoms or Conditions	138	141
Superficial (First Degree) Burn	33	33
Partial thickness (Second Degree) Burn	29	29
Full thickness (Third Degree) Burn	17	17
Blister	15	15
Pain	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Rash	5	5
Electric Shock	4	4
Skin Inflammation/ Irritation	4	4
Scar Tissue	4	4
Unspecified Infection	3	3
Impaired Healing	3	3
Burn, Thermal	3	3
Erythema	3	3
Undesired Nerve Stimulation	3	3
Unspecified Tissue Injury	3	3
Dry Eye(s)	2	2
Discomfort	2	2
Fluid Discharge	2	2
Skin Burning Sensation	2	2
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
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