TPLC - Total Product Life Cycle

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Device	pads, menstrual, scented-deodorized
Definition	A scented or scented deodorized pad is a device made of common cellulosic or synthetic material with an established safety profile. This does not include menstrual pads treated with added antimicrobial agents. These are used to absorb menstrual or other vaginal discharge. These are class i exempt device.
Product Code	NRC
Regulation Number	884.5425
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Patient Device Interaction Problem	3	3
Product Quality Problem	3	3
Device Emits Odor	2	2
Chemical Problem	1	1
Improper Chemical Reaction	1	1
Use of Device Problem	1	1
Material Discolored	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burning Sensation	16	16
Pain	5	5
Skin Inflammation/ Irritation	4	4
Itching Sensation	3	3
Irritation	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hypersensitivity/Allergic reaction	2	2
Swelling	2	2
Discomfort	2	2
Unspecified Infection	1	1
Superficial (First Degree) Burn	1	1
Skin Infection	1	1
Inflammation	1	1
Localized Skin Lesion	1	1
Skin Discoloration	1	1
No Known Impact Or Consequence To Patient	1	1
Numbness	1	1
Dyspnea	1	1
Reaction	1	1
Anaphylactic Shock	1	1
Swelling/ Edema	1	1
Caustic/Chemical Burns	1	1
Tissue Breakdown	1	1
Full thickness (Third Degree) Burn	1	1
Skin Burning Sensation	1	1