TPLC - Total Product Life Cycle

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Device	pads, menstrual, scented-deodorized
Regulation Description	Scented or scented deodorized menstrual pad.
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
Adverse Event Without Identified Device or Use Problem	5	5
Patient-Device Incompatibility	4	4
Patient Device Interaction Problem	3	3
Product Quality Problem	3	3
Use of Device Problem	2	2
Device Emits Odor	2	2
Chemical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burning Sensation	23	23
Pain	7	7
Skin Inflammation/ Irritation	6	6
Discomfort	4	4
Itching Sensation	3	3
Unspecified Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hypersensitivity/Allergic reaction	2	2
Irritation	2	2
Skin Infection	1	1
Superficial (First Degree) Burn	1	1
Urinary Incontinence	1	1
Abnormal Vaginal Discharge	1	1
Inflammation	1	1
Localized Skin Lesion	1	1
Skin Discoloration	1	1
Foreign Body Reaction	1	1
Numbness	1	1
Swelling/ Edema	1	1
Tissue Breakdown	1	1
Skin Burning Sensation	1	1
Urinary Tract Infection	1	1