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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pad, menstrual, scented, scented-deodorized
Regulation Description Scented or scented deodorized menstrual pad.
Definition Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).
Product CodeHHL
Regulation Number 884.5425
Device Class 2

MDR Year MDR Reports MDR Events
2022 1 1
2023 5 5
2024 1 1
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 13 13
Patient Device Interaction Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fungal Infection 4 4
Burning Sensation 4 4
Pain 4 4
Hypersensitivity/Allergic reaction 3 3
Skin Infection 2 2
Caustic/Chemical Burns 2 2
Bacterial Infection 2 2
Urinary Tract Infection 2 2
Menstrual Irregularities 1 1
Dizziness 1 1
Skin Inflammation/ Irritation 1 1
Cyst(s) 1 1
Malaise 1 1
Itching Sensation 1 1
Blister 1 1
Localized Skin Lesion 1 1
Skin Discoloration 1 1
Paresthesia 1 1
Burn(s) 1 1
Rash 1 1
Diarrhea 1 1
Discomfort 1 1
Peeling 1 1
Dysphagia/ Odynophagia 1 1
Urinary Frequency 1 1
Subcutaneous Nodule 1 1
Angioedema 1 1

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