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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 14
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 183 183
Product Quality Problem 125 125
Manufacturing, Packaging or Shipping Problem 3 3
Appropriate Term/Code Not Available 3 3
Insufficient Information 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 153 153
Choking 41 41
No Code Available 30 30
Cancer 7 7
Hemorrhage/Bleeding 5 5
Foreign Body In Patient 5 5
Cough 4 4
Anaphylactic Shock 4 4
Death 4 4
Pneumonia 3 3
Vomiting 3 3
Burning Sensation 3 3
Pyrosis/Heartburn 3 3
Abdominal Pain 3 3
Nausea 3 3
Hypersensitivity/Allergic reaction 3 3
Angioedema 2 2
Sore Throat 2 2
Salivary Hypersecretion 2 2
Stroke/CVA 2 2
Pain 2 2
Dyspnea 2 2
Discomfort 2 2
Stomach Ulceration 2 2
Injury 2 2
Irritation 2 2
Obstruction/Occlusion 2 2
Aspiration/Inhalation 2 2
Fungal Infection 2 2
Seizures 2 2
Rash 1 1
Pancreatitis 1 1
Burn(s) 1 1
Suffocation 1 1
Paresthesia 1 1
Chest Pain 1 1
Diarrhea 1 1
Urinary Retention 1 1
Pneumothorax 1 1
Hernia 1 1
Confusion/ Disorientation 1 1
Dry Mouth 1 1
Gastritis 1 1
Renal Impairment 1 1
Bone Fracture(s) 1 1
Reaction 1 1
Heart Failure/Congestive Heart Failure 1 1
Arrhythmia 1 1
Foreign Body Sensation in Eye 1 1
Encephalopathy 1 1

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