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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
Product CodeKOT
Regulation Number 872.3490
Device Class 1

MDR Year MDR Reports MDR Events
2019 54 54
2020 90 90
2021 88 88
2022 51 51
2023 71 71
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 216 216
Product Quality Problem 137 137
Appropriate Term/Code Not Available 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Loss of or Failure to Bond 3 3
Patient-Device Incompatibility 3 3
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Nonstandard Device 1 1
Human-Device Interface Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 151 151
No Code Available 48 48
Choking 48 48
Cancer 15 15
Death 8 8
Vomiting 7 7
Foreign Body In Patient 6 6
Pneumonia 5 5
Hemorrhage/Bleeding 5 5
Anaphylactic Shock 4 4
Cough 4 4
Fungal Infection 3 3
Obstruction/Occlusion 3 3
Abdominal Pain 3 3
Hypersensitivity/Allergic reaction 3 3
Burning Sensation 3 3
Nausea 3 3
Pyrosis/Heartburn 3 3
Pain 2 2
Diarrhea 2 2
Irritation 2 2
Seizures 2 2
Dyspnea 2 2
Stroke/CVA 2 2
Arrhythmia 2 2
Aspiration/Inhalation 2 2
Patient Problem/Medical Problem 2 2
Meningitis 2 2
Sore Throat 2 2
Injury 2 2
Chemical Exposure 2 2
Salivary Hypersecretion 2 2
Stomach Ulceration 2 2
Angioedema 2 2
Renal Impairment 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Hypervolemia 1 1
Pancreatitis 1 1
Dry Mouth 1 1
Constipation 1 1
Paresthesia 1 1
Heart Failure/Congestive Heart Failure 1 1
Malaise 1 1
Pneumothorax 1 1
Rash 1 1
Reaction 1 1
Respiratory Tract Infection 1 1
Full thickness (Third Degree) Burn 1 1
Fibrosis 1 1
Sensitivity of Teeth 1 1
Confusion/ Disorientation 1 1
Burn(s) 1 1
Cataract 1 1
Chest Pain 1 1
Airway Obstruction 1 1
Encephalopathy 1 1
Foreign Body Sensation in Eye 1 1
Bone Fracture(s) 1 1
Gastritis 1 1
High Blood Pressure/ Hypertension 1 1
Inflammation 1 1
Skin Discoloration 1 1
Suffocation 1 1
Swelling 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Tingling 1 1
Uremia 1 1
Hernia 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Ischemia 1 1
Dysphagia/ Odynophagia 1 1
Neuropathy 1 1

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