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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device toothbrush, powered
Product CodeJEQ
Regulation Number 872.6865
Device Class 1


Premarket Reviews
ManufacturerDecision
THE PROCTER & GAMBLE COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 385 385
2020 433 433
2021 551 551
2022 611 611
2023 567 567
2024 138 138

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 707 707
Break 646 646
No Apparent Adverse Event 419 419
Loose or Intermittent Connection 255 255
Insufficient Information 116 116
Patient Device Interaction Problem 113 113
Mechanical Problem 97 97
Device Slipped 94 94
Material Fragmentation 79 79
Overheating of Device 71 71
Electrical /Electronic Property Problem 66 66
Material Separation 64 64
Fire 63 63
Connection Problem 61 61
Device Fell 57 57
Temperature Problem 45 45
Arcing 26 26
Naturally Worn 24 24
Smoking 24 24
Adverse Event Without Identified Device or Use Problem 17 17
Product Quality Problem 17 17
Explosion 16 16
Device Dislodged or Dislocated 16 16
Crack 13 13
Noise, Audible 13 13
Thermal Decomposition of Device 11 11
Device Emits Odor 11 11
Vibration 10 10
Sparking 9 9
Fitting Problem 9 9
Defective Device 9 9
Output Problem 9 9
Degraded 8 8
Melted 8 8
Appropriate Term/Code Not Available 7 7
Separation Problem 7 7
Sharp Edges 6 6
Burst Container or Vessel 6 6
Battery Problem 5 5
Charging Problem 5 5
Component Missing 5 5
Material Protrusion/Extrusion 5 5
Loss of Power 4 4
Leak/Splash 4 4
Excessive Heating 4 4
Material Split, Cut or Torn 4 4
Structural Problem 4 4
Material Integrity Problem 4 4
Unstable 4 4
Material Disintegration 4 4
Patient-Device Incompatibility 4 4
Failure to Cycle 3 3
Defective Component 3 3
Material Discolored 3 3
Improper or Incorrect Procedure or Method 3 3
Material Puncture/Hole 3 3
Use of Device Problem 3 3
Failure to Charge 3 3
Inadequacy of Device Shape and/or Size 3 3
Electrical Shorting 3 3
Physical Resistance/Sticking 3 3
Material Deformation 3 3
Entrapment of Device 3 3
Disconnection 3 3
Scratched Material 3 3
Failure to Align 3 3
Fluid/Blood Leak 3 3
Microbial Contamination of Device 2 2
Mechanics Altered 2 2
Deformation Due to Compressive Stress 2 2
Contamination /Decontamination Problem 2 2
Corroded 2 2
Misconnection 2 2
Unintended Electrical Shock 2 2
Migration or Expulsion of Device 2 2
Material Twisted/Bent 1 1
Human-Device Interface Problem 1 1
Difficult to Remove 1 1
Computer System Security Problem 1 1
Contamination 1 1
Flare or Flash 1 1
Energy Output Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Material Frayed 1 1
Therapeutic or Diagnostic Output Failure 1 1
Delayed Charge Time 1 1
Material Erosion 1 1
Positioning Problem 1 1
Battery Problem: Low Impedance 1 1
Electrical Overstress 1 1
Nonstandard Device 1 1
Stretched 1 1
Device Contamination with Chemical or Other Material 1 1
Unintended Movement 1 1
Material Too Rigid or Stiff 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1490 1490
No Consequences Or Impact To Patient 342 342
Unspecified Tissue Injury 150 150
Tooth Fracture 131 131
No Known Impact Or Consequence To Patient 102 102
Laceration(s) 88 88
Pain 81 81
Foreign Body In Patient 78 78
Choking 76 76
Hemorrhage/Bleeding 73 73
Insufficient Information 70 70
Injury 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Burn(s) 19 19
Discomfort 16 16
No Patient Involvement 14 14
Electric Shock 10 10
Abrasion 9 9
Skin Inflammation/ Irritation 7 7
Device Embedded In Tissue or Plaque 6 6
No Code Available 6 6
Erosion 6 6
Cough 5 5
Patient Problem/Medical Problem 5 5
Sensitivity of Teeth 4 4
Tinnitus 4 4
Vomiting 3 3
Chemical Exposure 3 3
Swelling/ Edema 3 3
Caustic/Chemical Burns 2 2
Superficial (First Degree) Burn 2 2
Tissue Damage 2 2
Scar Tissue 2 2
Bruise/Contusion 2 2
Irritation 2 2
Itching Sensation 2 2
Dyspnea 2 2
Eye Injury 1 1
Asphyxia 1 1
Fever 1 1
Bone Fracture(s) 1 1
Headache 1 1
Abscess 1 1
Airway Obstruction 1 1
Aspiration/Inhalation 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Infection 1 1
Inflammation 1 1
Scarring 1 1
Skin Discoloration 1 1
Swelling 1 1
Burning Sensation 1 1
Abdominal Pain 1 1
Complaint, Ill-Defined 1 1
Hypoesthesia 1 1
Sore Throat 1 1
Respiratory Tract Infection 1 1
Irritability 1 1
Burn, Thermal 1 1
Unspecified Eye / Vision Problem 1 1
Hematemesis 1 1
Stomatitis 1 1
Skin Disorders 1 1
Skin Infection 1 1
Paresthesia 1 1
Foreign Body Embolism 1 1
No Information 1 1
Increased Appetite 1 1

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