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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
2014 4 4
2015 6 6
2016 4 4
2017 4 4
2018 5 5
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
Patient-Device Incompatibility 16 16
Device Emits Odor 15 15
Adverse Event Without Identified Device or Use Problem 9 9
Insufficient Information 6 6
Patient Device Interaction Problem 3 3
Device Markings/Labelling Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Product Quality Problem 2 2
Material Separation 2 2
Material Fragmentation 2 2
Nonstandard Device 1 1
Contamination /Decontamination Problem 1 1
Unraveled Material 1 1
Use of Device Problem 1 1
Failure to Advance 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Packaging Problem 1 1
Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Itching Sensation 16 16
Rash 14 14
Skin Inflammation/ Irritation 12 12
Hypersensitivity/Allergic reaction 10 10
Nausea 8 8
Burning Sensation 8 8
Pain 7 7
Erythema 7 7
Urinary Tract Infection 5 5
Caustic/Chemical Burns 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Unspecified Infection 4 4
Swelling 3 3
Urinary Frequency 3 3
No Known Impact Or Consequence To Patient 3 3
Ambulation Difficulties 2 2
Hematuria 2 2
Vomiting 2 2
Inflammation 2 2
Skin Discoloration 2 2
Bacterial Infection 2 2
Peeling 2 2
Local Reaction 2 2
Scar Tissue 1 1
Sepsis 1 1
Pneumonia 1 1
Cellulitis 1 1
Cyst(s) 1 1
Dyspnea 1 1
Hemorrhage/Bleeding 1 1
Incontinence 1 1
Skin Irritation 1 1
Irritation 1 1
Weakness 1 1
Toxic Shock Syndrome 1 1
Urticaria 1 1
Discomfort 1 1
Injury 1 1
Reaction 1 1
Numbness 1 1
Skin Inflammation 1 1
Sleep Dysfunction 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
Anaphylactoid 1 1
Full thickness (Third Degree) Burn 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

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