TPLC - Total Product Life Cycle

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Device	lamp, infrared, therapeutic heating
Regulation Description	Infrared lamp.
Product Code	ILY
Regulation Number	890.5500
Device Class	2

Premarket Reviews
Manufacturer	Decision
CURE POINT THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CYTONSYS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GIGAALASER COMPANY , LTD.
	SUBSTANTIALLY EQUIVALENT	1
LIGHT TREE VENTURES EUROPE B.V.
	SUBSTANTIALLY EQUIVALENT	1
LTBIO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN PHOMED TECHNOLOGY COMPANY , LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Excessive Heating	19	19
Temperature Problem	11	11
Adverse Event Without Identified Device or Use Problem	8	8
Patient-Device Incompatibility	5	5
Use of Device Problem	4	4
Overheating of Device	4	4
Device Markings/Labelling Problem	3	3
Insufficient Information	3	3
Material Integrity Problem	2	2
Device-Device Incompatibility	1	1
Break	1	1
Off-Label Use	1	1
Physical Resistance/Sticking	1	1
Unintended Power Up	1	1
Device Fell	1	1
Smoking	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Clean Adequately	1	1
Patient Device Interaction Problem	1	1
Structural Problem	1	1
Device Handling Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Device Emits Odor	1	2
Product Quality Problem	1	1
Difficult to Open or Close	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burning Sensation	13	13
Burn(s)	11	11
No Clinical Signs, Symptoms or Conditions	10	10
Skin Burning Sensation	5	5
Superficial (First Degree) Burn	5	5
Erythema	4	4
Headache	4	5
Partial thickness (Second Degree) Burn	4	4
Dizziness	3	4
Blister	3	3
Rash	3	3
Chest Pain	3	3
Insufficient Information	3	3
Swelling/ Edema	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Gastrointestinal Problem	2	2
Hemorrhage/Bleeding	2	2
Unspecified Respiratory Problem	2	3
Numbness	2	2
Eye Injury	2	2
Bruise/Contusion	1	1
Swollen Lymph Nodes/Glands	1	2
Dementia	1	1
Full thickness (Third Degree) Burn	1	1
Sore Throat	1	2
Inadequate Pain Relief	1	1
Deformity/ Disfigurement	1	1
Loss of Vision	1	1
Convulsion/Seizure	1	1
Hypoxia	1	1
Undesired Nerve Stimulation	1	1
Vitreous Hemorrhage	1	1
Scar Tissue	1	1
Pain	1	1
Dyspnea	1	1
Unspecified Eye / Vision Problem	1	2
Discomfort	1	1
Viral Infection	1	1
Localized Skin Lesion	1	1
Eye Burn	1	1
Tics/Tremor	1	1
Inflammation	1	2
Aspiration/Inhalation	1	1
Skin Inflammation/ Irritation	1	1
Necrosis	1	1
Red Eye(s)	1	2
Nausea	1	2
High Blood Pressure/ Hypertension	1	1