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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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 246 246
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 178 178
No Code Available 37 37
Hypersensitivity/Allergic reaction 10 10
Pain 8 8
Choking 6 6
Discomfort 5 5
Abdominal Pain 4 4
Burning Sensation 4 4
Nausea 4 4
Hemorrhage/Bleeding 3 3
Inflammation 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Sore Throat 2 2
Vomiting 2 2
Swelling 2 2
Dementia 2 2
Cancer 2 2
Foreign Body In Patient 2 2
Swelling/ Edema 2 2
Dyspnea 2 2
Death 2 2
Chemical Exposure 1 1
Tissue Breakdown 1 1
Decreased Appetite 1 1
Skin Inflammation/ Irritation 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Hypoxia 1 1
Dysgeusia 1 1
Hallucination 1 1
Unspecified Respiratory Problem 1 1
Salivary Gland Problem 1 1
Dry Mouth 1 1
Stomach Ulceration 1 1
Liver Damage/Dysfunction 1 1
Memory Loss/Impairment 1 1
Fever 1 1
Erythema 1 1
Pneumonia 1 1
Shock 1 1
Diarrhea 1 1
Dizziness 1 1
Chest Pain 1 1
Malaise 1 1
Infarction, Cerebral 1 1
Reaction 1 1
Numbness 1 1
Loss of consciousness 1 1
Bronchitis 1 1
Ambulation Difficulties 1 1
Cognitive Changes 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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