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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device carboxymethylcellulose sodium or polyvinyl methylether maleic acid calcium-sodium
Regulation Description Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.
Product CodeKOT
Regulation Number 872.3490
Device Class 1

MDR Year MDR Reports MDR Events
2020 90 90
2021 88 88
2022 51 51
2023 71 71
2024 14 15
2025 3 3
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 183 184
Product Quality Problem 126 126
Manufacturing, Packaging or Shipping Problem 3 3
Appropriate Term/Code Not Available 3 3
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Device Emits Odor 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 153 154
Choking 41 41
No Code Available 30 30
Cancer 7 7
Foreign Body In Patient 6 6
Hemorrhage/Bleeding 5 5
Nausea 5 5
Death 4 4
Hypersensitivity/Allergic reaction 4 4
Cough 4 4
Anaphylactic Shock 4 4
Vomiting 4 4
Abdominal Pain 3 3
Pneumonia 3 3
Burning Sensation 3 3
Pyrosis/Heartburn 3 3
Angioedema 2 2
Sore Throat 2 2
Salivary Hypersecretion 2 2
Dyspnea 2 2
Pain 2 2
Discomfort 2 3
Stomach Ulceration 2 2
Irritation 2 2
Injury 2 2
Obstruction/Occlusion 2 2
Aspiration/Inhalation 2 2
Fungal Infection 2 2
Seizures 2 2
Stroke/CVA 2 2
Paresthesia 1 1
Confusion/ Disorientation 1 1
Itching Sensation 1 1
Burn(s) 1 1
Rash 1 1
Gastritis 1 1
Diarrhea 1 1
Bone Fracture(s) 1 1
Chest Pain 1 1
Urinary Retention 1 1
Hernia 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Renal Impairment 1 1
Reaction 1 1
Heart Failure/Congestive Heart Failure 1 1
Pancreatitis 1 1
Arrhythmia 1 1
Pneumothorax 1 1
Dry Mouth 1 1
Suffocation 1 1

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