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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pad, menstrual, unscented
Product CodeHHD
Regulation Number 884.5435
Device Class 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 2 2
2021 5 5
2022 8 8
2023 16 16
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Emits Odor 13 13
Adverse Event Without Identified Device or Use Problem 5 5
Patient-Device Incompatibility 4 4
Device Markings/Labelling Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Patient Device Interaction Problem 3 3
Insufficient Information 2 2
Material Fragmentation 2 2
Product Quality Problem 2 2
Material Separation 2 2
Unraveled Material 1 1
Use of Device Problem 1 1
Contamination /Decontamination Problem 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 12 12
Itching Sensation 9 9
Nausea 8 8
Rash 7 7
No Clinical Signs, Symptoms or Conditions 5 5
Burning Sensation 3 3
Erythema 3 3
Bacterial Infection 2 2
Pain 2 2
Hypersensitivity/Allergic reaction 2 2
Unspecified Infection 2 2
Urinary Frequency 2 2
Vomiting 2 2
Caustic/Chemical Burns 2 2
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Skin Infection 1 1
Unspecified Tissue Injury 1 1
Reaction to Medicinal Component of Device 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Abdominal Pain 1 1
Discomfort 1 1
Sleep Dysfunction 1 1
Sepsis 1 1
Swelling 1 1
Toxic Shock Syndrome 1 1
Urinary Tract Infection 1 1
Inflammation 1 1
Cyst(s) 1 1
Hemorrhage/Bleeding 1 1

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