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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
Entrapment of Device 7 7
Device Operates Differently Than Expected 7 7
Product Quality Problem 6 6
Material Fragmentation 5 5
Physical Resistance/Sticking 5 5
Human-Device Interface Problem 4 4
Material Integrity Problem 4 4
Difficult to Remove 4 4
Use of Device Problem 4 4
Device Dislodged or Dislocated 4 4
Material Separation 3 3
Patient Device Interaction Problem 3 3
Sharp Edges 3 3
Appropriate Term/Code Not Available 3 3
Sticking 2 2
Material Frayed 2 2
Improper or Incorrect Procedure or Method 2 2
Device Markings/Labelling Problem 2 2
Device Contamination with Chemical or Other Material 1 1
Failure to Select Signal 1 1
Device Slipped 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Component 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
Structural Problem 1 1
Device Damaged by Another Device 1 1
Crack 1 1
Material Erosion 1 1
Device Fell 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
Laceration(s) 3 3
Discomfort 3 3
Dyspnea 2 2
Numbness 2 2
Irritation 2 2
Itching Sensation 2 2
Malaise 2 2
Nausea 2 2
Complaint, Ill-Defined 2 2
Urticaria 2 2
Angina 1 1
Rash 1 1
Device Overstimulation of Tissue 1 1
Pharyngitis 1 1
Anaphylactoid 1 1
Vomiting 1 1
Local Reaction 1 1
Skin Inflammation/ Irritation 1 1
Failure of Implant 1 1
Radiation Underdose 1 1
Choking 1 1
Abscess 1 1
Anaphylactic Shock 1 1
Dysphagia/ Odynophagia 1 1
Unspecified Tissue Injury 1 1
Myocardial Infarction 1 1
Tissue Damage 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Tingling 1 1
Wheal(s) 1 1
Syncope/Fainting 1 1

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