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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
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
Break 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Insufficient Information 8 8
Entrapment of Device 3 3
Patient Device Interaction Problem 3 3
Detachment of Device or Device Component 3 3
Material Fragmentation 2 2
Product Quality Problem 2 2
Device Slipped 1 1
Physical Resistance/Sticking 1 1
Patient-Device Incompatibility 1 1
Material Too Rigid or Stiff 1 1
Use of Device Problem 1 1
Material Separation 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 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Clinical Signs, Symptoms or Conditions 6 6
Foreign Body In Patient 6 6
Insufficient Information 6 6
Discomfort 3 3
Pain 3 3
Device Embedded In Tissue or Plaque 3 3
Nausea 2 2
Inflammation 2 2
Malaise 2 2
Unspecified Infection 1 1
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
Skin Burning Sensation 1 1

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