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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device adhesive, denture, polyvinyl methylether maleic acid calcium-sodium double salt
Regulation Description Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.
Product CodeKOO
Regulation Number 872.3490
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 1 1
2023 5 5
2024 29 29
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14 14
Appropriate Term/Code Not Available 12 12
Product Quality Problem 8 8
Adhesive Too Strong 2 2
Device Markings/Labelling Problem 1 1
Patient-Device Incompatibility 1 1
Therapeutic or Diagnostic Output Failure 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 23 23
Cough 5 5
Choking 5 5
Foreign Body In Patient 3 3
Swelling/ Edema 3 3
Unspecified Gastrointestinal Problem 2 2
Pneumonia 2 2
Constipation 2 2
Hemorrhage/Bleeding 2 2
Tooth Fracture 2 2
Discomfort 2 2
Stomatitis 1 1
Salivary Hypersecretion 1 1
Respiratory Arrest 1 1
No Code Available 1 1
Fibrosis 1 1
Patch Test, Abnormal Results Of 1 1
Weight Changes 1 1
Skin Tears 1 1
Decreased Respiratory Rate 1 1
Irregular Pulse 1 1
Loss of consciousness 1 1
Numbness 1 1
Sore Throat 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Solid Tumour 1 1
Eczema 1 1
Blister 1 1
Unspecified Infection 1 1
High Blood Pressure/ Hypertension 1 1
Dyspnea 1 1
Dysphagia/ Odynophagia 1 1
Dehydration 1 1
Bacterial Infection 1 1
Anaphylactic Shock 1 1
Airway Obstruction 1 1
Dizziness 1 1
Burning Sensation 1 1
Vomiting 1 1
Pain 1 1
Myocardial Infarction 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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