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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device floss, dental
Regulation Description Dental floss.
Product CodeJES
Regulation Number 872.6390
Device Class 1

MDR Year MDR Reports MDR Events
2020 32 32
2021 32 32
2022 8 8
2023 3 3
2024 6 6
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 19 19
Break 17 17
Detachment of Device or Device Component 17 17
Insufficient Information 8 8
Physical Resistance/Sticking 4 4
Entrapment of Device 3 3
Patient Device Interaction Problem 3 3
Material Fragmentation 3 3
Product Quality Problem 3 3
Material Separation 2 2
Device Slipped 1 1
Crack 1 1
Patient-Device Incompatibility 1 1
Material Too Rigid or Stiff 1 1
Use of Device Problem 1 1
Structural Problem 1 1
Sharp Edges 1 1
Failure to Select Signal 1 1
Device Contamination with Chemical or Other Material 1 1
Appropriate Term/Code Not Available 1 1
Human-Device Interface Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 20 20
No Known Impact Or Consequence To Patient 15 15
No Clinical Signs, Symptoms or Conditions 11 11
Foreign Body In Patient 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
No Code Available 6 6
Insufficient Information 6 6
Inflammation 5 5
Discomfort 3 3
Pain 3 3
Device Embedded In Tissue or Plaque 3 3
Unspecified Infection 2 2
Nausea 2 2
Malaise 2 2
Urticaria 1 1
Syncope/Fainting 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Skin Inflammation/ Irritation 1 1
Pharyngitis 1 1
Device Overstimulation of Tissue 1 1
Angina 1 1
Vomiting 1 1
Dyspnea 1 1
Choking 1 1
Reaction 1 1
Unspecified Tissue Injury 1 1
Myocardial Infarction 1 1
Erosion 1 1
Hemorrhage/Bleeding 1 1
Wheal(s) 1 1
Sensitivity of Teeth 1 1
Skin Burning Sensation 1 1

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