TPLC - Total Product Life Cycle

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Device	pad, menstrual, scented, scented-deodorized made of common cellulosic & synthetic material w/established safety profile
Regulation Description	Scented or scented deodorized menstrual pad.
Definition	Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, not intended as intralabial pads or reusable menstrual pads. These are made of common cellulosic or synthetic material with an established safety profile.
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	4	4
Device Emits Odor	2	2
Product Quality Problem	2	2
Use of Device Problem	2	2
Chemical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burning Sensation	23	23
Pain	8	8
Skin Inflammation/ Irritation	6	6
Itching Sensation	4	4
Hypersensitivity/Allergic reaction	3	3
Discomfort	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Swelling/ Edema	2	2
Skin Infection	1	1
Superficial (First Degree) Burn	1	1
Unspecified Infection	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
Skin Burning Sensation	1	1
Urinary Tract Infection	1	1