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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2019 52 52
2020 32 32
2021 32 32
2022 8 8
2023 3 3
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 35 35
Detachment of Device or Device Component 32 32
Break 21 21
Insufficient Information 7 7
Product Quality Problem 6 6
Physical Resistance/Sticking 5 5
Entrapment of Device 3 3
Patient Device Interaction Problem 3 3
Material Fragmentation 3 3
Sharp Edges 3 3
Material Separation 3 3
Material Frayed 2 2
Patient-Device Incompatibility 2 2
Material Integrity Problem 2 2
Use of Device Problem 2 2
Device Slipped 1 1
Crack 1 1
Device Markings/Labelling Problem 1 1
Defective Component 1 1
Material Too Rigid or Stiff 1 1
Material Twisted/Bent 1 1
Structural Problem 1 1
Device Damaged by Another Device 1 1
Failure to Select Signal 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 38 38
Foreign Body In Patient 20 20
Tooth Fracture 19 19
No Code Available 16 16
No Clinical Signs, Symptoms or Conditions 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Inflammation 6 6
Insufficient Information 6 6
Pain 6 6
Hypersensitivity/Allergic reaction 4 4
Discomfort 3 3
Sensitivity of Teeth 3 3
Device Embedded In Tissue or Plaque 3 3
Unspecified Infection 2 2
Nausea 2 2
No Information 2 2
Malaise 2 2
Swelling 2 2
Urticaria 1 1
Syncope/Fainting 1 1
Failure of Implant 1 1
Skin Inflammation/ Irritation 1 1
Itching Sensation 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
Headache 1 1
Hemorrhage/Bleeding 1 1
Wheal(s) 1 1
Skin Burning Sensation 1 1

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