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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
Product CodeEFT
Regulation Number 872.3520
Device Class 1

MDR Year MDR Reports MDR Events
2019 55 55
2020 68 68
2021 74 74
2022 40 40
2023 44 44
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 254 254
Improper or Incorrect Procedure or Method 11 11
Product Quality Problem 10 10
Patient-Device Incompatibility 8 8
Patient Device Interaction Problem 3 3
Appropriate Term/Code Not Available 2 2
Naturally Worn 1 1
Use of Device Problem 1 1
Expiration Date Error 1 1
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 144 144
No Code Available 76 76
Hypersensitivity/Allergic reaction 8 8
Foreign Body In Patient 8 8
Choking 6 6
Hemorrhage/Bleeding 6 6
Pain 5 5
Nausea 4 4
Burning Sensation 3 3
Discomfort 3 3
Reaction 3 3
Abdominal Pain 3 3
Death 3 3
Dyspnea 2 2
Inflammation 2 2
Sore Throat 2 2
Swelling 2 2
Cancer 2 2
Dementia 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Swelling/ Edema 2 2
Patient Problem/Medical Problem 1 1
Ambulation Difficulties 1 1
Cognitive Changes 1 1
Chemical Exposure 1 1
Complete Heart Block 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Hallucination 1 1
Salivary Gland Problem 1 1
Dry Mouth 1 1
Stomach Ulceration 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Skin Inflammation/ Irritation 1 1
Decreased Appetite 1 1
Vomiting 1 1
Numbness 1 1
Loss of consciousness 1 1
Itching Sensation 1 1
Liver Damage/Dysfunction 1 1
Memory Loss/Impairment 1 1
Pneumonia 1 1
Rash 1 1
Respiratory Distress 1 1
Seizures 1 1
Shock 1 1
Erythema 1 1
Fever 1 1
Bronchitis 1 1
Breast Cancer 1 1
Infarction, Cerebral 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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