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TPLC
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Device
cleanser, denture, over the counter
Regulation Description
OTC denture cleanser.
Product Code
EFT
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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