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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
2018 743 743
2019 385 385
2020 433 433
2021 551 551
2022 611 611
2023 498 498

Device Problems MDRs with this Device Problem Events in those MDRs
Break 859 859
Detachment of Device or Device Component 794 794
Missing Value Reason 319 319
Loose or Intermittent Connection 292 292
No Apparent Adverse Event 267 267
Patient Device Interaction Problem 146 146
Detachment Of Device Component 111 111
Device Slipped 101 101
Mechanical Problem 97 97
Insufficient Information 89 89
Material Fragmentation 83 83
Material Separation 71 71
Device Fell 68 68
Overheating of Device 64 64
Fire 64 64
Electrical /Electronic Property Problem 64 64
Connection Problem 62 62
Temperature Problem 60 60
Smoking 28 28
Arcing 26 26
Naturally Worn 24 24
Device Dislodged or Dislocated 20 20
Product Quality Problem 19 19
Vibration 17 17
Component Falling 17 17
Adverse Event Without Identified Device or Use Problem 17 17
Noise, Audible 17 17
Explosion 17 17
Crack 15 15
Device Emits Odor 13 13
Melted 12 12
Thermal Decomposition of Device 11 11
Fitting Problem 11 11
Defective Device 11 11
Sparking 10 10
Appropriate Term/Code Not Available 9 9
Output Problem 9 9
Patient-Device Incompatibility 8 8
Degraded 8 8
Material Disintegration 7 7
Material Integrity Problem 7 7
Separation Problem 7 7
Sharp Edges 6 6
Material Protrusion/Extrusion 6 6
Burst Container or Vessel 6 6
Component Missing 6 6
Defective Component 5 5
Battery Problem 5 5
Charging Problem 5 5
Leak/Splash 5 5
Entrapment of Device 5 5
Scratched Material 5 5
Material Split, Cut or Torn 4 4
Device Contamination with Chemical or Other Material 4 4
Fluid/Blood Leak 4 4
Hole In Material 4 4
Material Discolored 4 4
Corroded 4 4
Loss of Power 4 4
Unstable 4 4
Use of Device Problem 4 4
Device Operates Differently Than Expected 4 4
Structural Problem 4 4
Failure to Align 3 3
Microbial Contamination of Device 3 3
Improper or Incorrect Procedure or Method 3 3
Material Puncture/Hole 3 3
Inadequacy of Device Shape and/or Size 3 3
Failure to Cycle 3 3
Disconnection 3 3
Failure to Charge 3 3
Unintended Ejection 3 3
Electrical Shorting 3 3
Physical Resistance/Sticking 3 3
Material Deformation 3 3
Mechanics Altered 3 3
Excessive Heating 3 3
Unintended Movement 2 2
Unintended Electrical Shock 2 2
Flare or Flash 2 2
Device Inoperable 2 2
Migration or Expulsion of Device 2 2
Misconnection 2 2
Deformation Due to Compressive Stress 2 2
Contamination /Decontamination Problem 2 2
Computer System Security Problem 1 1
Delayed Charge Time 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Remove Packaging Material 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Sticking 1 1
Device Stops Intermittently 1 1
Stretched 1 1
Nonstandard Device 1 1
Unintended Collision 1 1
Energy Output Problem 1 1
Material Frayed 1 1
Material Erosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1318 1318
No Consequences Or Impact To Patient 700 700
No Known Impact Or Consequence To Patient 246 246
Tooth Fracture 165 165
Unspecified Tissue Injury 136 136
Injury 108 108
Laceration(s) 99 99
Choking 96 96
Foreign Body In Patient 96 96
Patient Problem/Medical Problem 95 95
Pain 88 88
Hemorrhage/Bleeding 83 83
Insufficient Information 70 70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
No Patient Involvement 19 19
Discomfort 18 18
Burn(s) 17 17
No Code Available 13 13
Electric Shock 11 11
Abrasion 10 10
No Information 9 9
Skin Inflammation/ Irritation 7 7
Sensitivity of Teeth 6 6
Device Embedded In Tissue or Plaque 6 6
Erosion 6 6
Itching Sensation 4 4
Tinnitus 4 4
Cough 4 4
Chemical Exposure 4 4
Reaction 3 3
Swelling/ Edema 3 3
Tissue Damage 3 3
Vomiting 3 3
Burning Sensation 3 3
Swelling 3 3
Irritation 3 3
Dyspnea 3 3
Bruise/Contusion 2 2
Headache 2 2
Unspecified Infection 2 2
Scar Tissue 2 2
Superficial (First Degree) Burn 2 2
Burn, Thermal 2 2
Caustic/Chemical Burns 2 2
Complaint, Ill-Defined 1 1
Hypoesthesia 1 1
Sore Throat 1 1
Respiratory Tract Infection 1 1
Irritability 1 1
Foreign Body Embolism 1 1
Increased Appetite 1 1
Unspecified Eye / Vision Problem 1 1
Stomatitis 1 1
Skin Disorders 1 1
Skin Infection 1 1
Scarring 1 1
Skin Discoloration 1 1
Inflammation 1 1
Myalgia 1 1
Dizziness 1 1
Hypersensitivity/Allergic reaction 1 1
Erythema 1 1
Eye Injury 1 1
Fatigue 1 1
Asphyxia 1 1
Fever 1 1
Bone Fracture(s) 1 1
Abscess 1 1
Airway Obstruction 1 1
Aspiration/Inhalation 1 1
Stroke/CVA 1 1
Contusion 1 1
Diarrhea 1 1

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