TPLC - Total Product Life Cycle

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Device	eyelid thermal pulsation system
Definition	Therapeutic application of heat and massage to the eyelids.
Product Code	ORZ
Regulation Number	886.5200
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	20	20
Appropriate Term/Code Not Available	2	2
Thermal Decomposition of Device	2	2
Delivered as Unsterile Product	2	2
Unsealed Device Packaging	1	1
Unexpected Therapeutic Results	1	1
Defective Device	1	1
Patient-Device Incompatibility	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	4	4
No Known Impact Or Consequence To Patient	4	4
No Code Available	4	4
Vitreous Floaters	3	3
Keratitis	3	3
Red Eye(s)	3	3
Bruise/Contusion	2	2
Unspecified Infection	2	2
Corneal Abrasion	2	2
Corneal Infiltrates	2	2
Excessive Tear Production	2	2
Eye Infections	2	2
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Eye Pain	1	1
Unspecified Eye / Vision Problem	1	1
Arthralgia	1	1
Inadequate Pain Relief	1	1
Vitreous Detachment	1	1
No Patient Involvement	1	1
Cough	1	1
Rash	1	1
Corneal Edema	1	1
Corneal Ulcer	1	1
Dry Eye(s)	1	1
Fatigue	1	1
Flashers	1	1
Inflammation	1	1
Iritis	1	1
Conjunctivitis	1	1
Erosion	1	1
Swelling	1	1
Blurred Vision	1	1
Visual Impairment	1	1
Loss of Vision	1	1
Burning Sensation	1	1