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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
2018 79 79
2019 55 55
2020 68 68
2021 74 74
2022 40 40
2023 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 225 225
Improper or Incorrect Procedure or Method 63 63
Patient-Device Incompatibility 15 15
Product Quality Problem 10 10
Insufficient Information 5 5
Use of Device Problem 4 4
Patient Device Interaction Problem 3 3
Appropriate Term/Code Not Available 1 1
Device Operates Differently Than Expected 1 1
Inadequate User Interface 1 1
Naturally Worn 1 1
Expiration Date Error 1 1
Break 1 1
Material Discolored 1 1
Labelling, Instructions for Use or Training Problem 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 113 113
No Code Available 87 87
Foreign Body In Patient 31 31
Hypersensitivity/Allergic reaction 11 11
Pain 7 7
Swelling 7 7
Burning Sensation 7 7
No Known Impact Or Consequence To Patient 7 7
Discomfort 7 7
Hemorrhage/Bleeding 7 7
Chemical Exposure 7 7
Complaint, Ill-Defined 6 6
Nausea 6 6
Death 5 5
Choking 5 5
Vomiting 4 4
Reaction 4 4
Inflammation 4 4
Itching Sensation 4 4
Irritation 3 3
Dyspnea 3 3
Abdominal Pain 2 2
Erythema 2 2
Pneumonia 2 2
Injury 2 2
Malaise 2 2
Sore Throat 2 2
Patient Problem/Medical Problem 2 2
No Clinical Signs, Symptoms or Conditions 2 2
No Information 2 2
Swelling/ Edema 2 2
Cancer 2 2
Dementia 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
Partial thickness (Second Degree) Burn 1 1
Numbness 1 1
Loss of consciousness 1 1
Low Oxygen Saturation 1 1
Ambulation Difficulties 1 1
Caustic/Chemical Burns 1 1
Cognitive Changes 1 1
Complete Heart Block 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Rash 1 1
Respiratory Distress 1 1
Seizures 1 1
Skin Erosion 1 1
Liver Damage/Dysfunction 1 1
Memory Loss/Impairment 1 1
Overdose 1 1
Immunodeficiency 1 1
Dizziness 1 1
Stenosis 1 1
Thrombosis 1 1
Tissue Damage 1 1
Peeling 1 1
Fatigue 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Aspiration/Inhalation 1 1
Bronchitis 1 1
Burn(s) 1 1
Breast Cancer 1 1
Infarction, Cerebral 1 1
Chest Pain 1 1
Edema 1 1
Diarrhea 1 1

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