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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


Premarket Reviews
ManufacturerDecision
PROCTER & GAMBLE CO.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 84 84
2015 45 45
2016 43 43
2017 50 50
2018 52 52
2019 52 52
2020 32 32
2021 32 32
2022 8 8
2023 3 3
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 186 186
Adverse Event Without Identified Device or Use Problem 67 67
Detachment of Device or Device Component 42 42
Insufficient Information 20 20
Detachment Of Device Component 19 19
Patient-Device Incompatibility 12 12
Device Operates Differently Than Expected 7 7
Entrapment of Device 7 7
Product Quality Problem 6 6
Material Fragmentation 5 5
Physical Resistance/Sticking 5 5
Device Dislodged or Dislocated 4 4
Material Integrity Problem 4 4
Use of Device Problem 4 4
Difficult to Remove 4 4
Human-Device Interface Problem 4 4
Sharp Edges 3 3
Appropriate Term/Code Not Available 3 3
Patient Device Interaction Problem 3 3
Material Separation 3 3
Material Frayed 2 2
Improper or Incorrect Procedure or Method 2 2
Device Markings/Labelling Problem 2 2
Sticking 2 2
Device Damaged by Another Device 1 1
Structural Problem 1 1
Device Slipped 1 1
Material Erosion 1 1
Device Fell 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Battery Problem 1 1
Degraded 1 1
Incorrect Device Or Component Shipped 1 1
Material Twisted/Bent 1 1
Material Too Rigid or Stiff 1 1
Crack 1 1
Failure to Select Signal 1 1
Device Contamination with Chemical or Other Material 1 1
Improper Chemical Reaction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 148 148
No Known Impact Or Consequence To Patient 72 72
Tooth Fracture 48 48
No Code Available 36 36
Foreign Body In Patient 28 28
Swelling 12 12
No Clinical Signs, Symptoms or Conditions 11 11
Reaction 10 10
Hypersensitivity/Allergic reaction 9 9
Pain 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Inflammation 8 8
No Information 7 7
Insufficient Information 6 6
Injury 5 5
Sensitivity of Teeth 4 4
Unspecified Infection 3 3
Device Embedded In Tissue or Plaque 3 3
Discomfort 3 3
Laceration(s) 3 3
Urticaria 2 2
Complaint, Ill-Defined 2 2
Nausea 2 2
Malaise 2 2
Itching Sensation 2 2
Irritation 2 2
Numbness 2 2
Dyspnea 2 2
Skin Burning Sensation 1 1
Wheal(s) 1 1
Hemorrhage/Bleeding 1 1
Headache 1 1
Myocardial Infarction 1 1
Tissue Damage 1 1
Unspecified Tissue Injury 1 1
Dysphagia/ Odynophagia 1 1
Anaphylactic Shock 1 1
Abscess 1 1
Choking 1 1
Radiation Underdose 1 1
Vomiting 1 1
Angina 1 1
Rash 1 1
Device Overstimulation of Tissue 1 1
Pharyngitis 1 1
Anaphylactoid 1 1
Local Reaction 1 1
Skin Inflammation/ Irritation 1 1
Failure of Implant 1 1
Tingling 1 1

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