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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cleanser, denture, over the counter
Regulation Description OTC denture cleanser.
Product CodeEFT
Regulation Number 872.3520
Device Class 1

MDR Year MDR Reports MDR Events
2020 68 68
2021 74 74
2022 40 40
2023 44 44
2024 42 42
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 252 252
Patient-Device Incompatibility 9 9
Product Quality Problem 7 7
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Labelling, Instructions for Use or Training Problem 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 182 182
No Code Available 37 37
Hypersensitivity/Allergic reaction 10 10
Pain 9 9
Discomfort 6 6
Choking 6 6
Burning Sensation 5 5
Abdominal Pain 4 4
Nausea 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Hemorrhage/Bleeding 3 3
Inflammation 3 3
Swelling/ Edema 2 2
Death 2 2
Dyspnea 2 2
Swelling 2 2
Vomiting 2 2
Dementia 2 2
Cancer 2 2
Sore Throat 2 2
Numbness 2 2
Foreign Body In Patient 2 2
Decreased Appetite 1 1
Skin Inflammation/ Irritation 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Stomach Ulceration 1 1
Dry Mouth 1 1
Salivary Gland Problem 1 1
Unspecified Respiratory Problem 1 1
Hallucination 1 1
Dysgeusia 1 1
Aphonia 1 1
Tissue Breakdown 1 1
Chemical Exposure 1 1
Cognitive Changes 1 1
Ambulation Difficulties 1 1
Loss of consciousness 1 1
Reaction 1 1
Malaise 1 1
Dizziness 1 1
Shock 1 1
Pneumonia 1 1
Memory Loss/Impairment 1 1
Liver Damage/Dysfunction 1 1
Laceration(s) 1 1
Hypoxia 1 1
Fever 1 1
Erythema 1 1
Diarrhea 1 1
Chest Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Nov-07-2023
2 Family Dollar Stores, Llc. II Aug-17-2022
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