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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
Product CodeKOO
Regulation Number 872.3490
Device Class 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 1 1
2022 1 1
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 3 3
Adhesive Too Strong 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Loss of or Failure to Bond 1 1
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 3 3
Hemorrhage/Bleeding 2 2
Pain 2 2
No Code Available 2 2
Respiratory Arrest 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Swelling 1 1
Vomiting 1 1
Burning Sensation 1 1
Complaint, Ill-Defined 1 1
Tooth Fracture 1 1
Decreased Respiratory Rate 1 1
Skin Tears 1 1
Hypersensitivity/Allergic reaction 1 1
Myocardial Infarction 1 1
Nausea 1 1
Patch Test, Abnormal Results Of 1 1
Airway Obstruction 1 1
Anaphylactic Shock 1 1
Dyspnea 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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