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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device adhesive, denture, carboxymethylcellulose sodium (32%) and ethylene-oxide homopolymer
Product CodeKOL
Regulation Number 872.3410
Device Class 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 2 2
2019 3 3
2020 5 5
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Product Quality Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 1 1
Material Deformation 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Choking 4 4
Pain 3 3
Sleep Dysfunction 2 2
Foreign Body In Patient 2 2
Ischemia 2 2
Discomfort 2 2
No Code Available 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Eye / Vision Problem 1 1
Patient Problem/Medical Problem 1 1
Visual Impairment 1 1
Anxiety 1 1
Diarrhea 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1

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