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
Material Discolored	1	1
Unexpected Therapeutic Results	1	1
Use of Device Problem	1	1
Chemical Problem	1	1
Improper Chemical Reaction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burning Sensation	15	15
Pain	5	5
Skin Inflammation/ Irritation	4	4
Irritation	3	3
Itching Sensation	3	3
Hypersensitivity/Allergic reaction	2	2
Discomfort	2	2
Swelling	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Swelling/ Edema	1	1
Reaction	1	1
Numbness	1	1
Caustic/Chemical Burns	1	1
Tissue Breakdown	1	1
Superficial (First Degree) Burn	1	1
No Known Impact Or Consequence To Patient	1	1
Full thickness (Third Degree) Burn	1	1
Skin Burning Sensation	1	1
Localized Skin Lesion	1	1
Skin Infection	1	1
Unspecified Infection	1	1
Inflammation	1	1
Anaphylactic Shock	1	1
Dyspnea	1	1
Skin Discoloration	1	1