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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 405 405

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 750 750
Break 646 646
No Apparent Adverse Event 578 578
Loose or Intermittent Connection 255 255
Insufficient Information 160 160
Patient Device Interaction Problem 113 113
Mechanical Problem 97 97
Device Slipped 94 94
Overheating of Device 83 83
Material Fragmentation 79 79
Electrical /Electronic Property Problem 67 67
Fire 65 65
Material Separation 64 64
Connection Problem 61 61
Device Fell 57 57
Temperature Problem 45 45
Arcing 26 26
Smoking 24 24
Naturally Worn 24 24
Adverse Event Without Identified Device or Use Problem 18 18
Product Quality Problem 17 17
Device Dislodged or Dislocated 16 16
Explosion 16 16
Crack 13 13
Noise, Audible 13 13
Thermal Decomposition of Device 11 11
Device Emits Odor 11 11
Vibration 10 10
Defective Device 9 9
Output Problem 9 9
Fitting Problem 9 9
Sparking 9 9
Appropriate Term/Code Not Available 8 8
Degraded 8 8
Melted 8 8
Separation Problem 7 7
Battery Problem 6 6
Burst Container or Vessel 6 6
Sharp Edges 6 6
Component Missing 5 5
Excessive Heating 5 5
Charging Problem 5 5
Material Protrusion/Extrusion 5 5
Unstable 4 4
Leak/Splash 4 4
Material Split, Cut or Torn 4 4
Material Disintegration 4 4
Patient-Device Incompatibility 4 4
Material Integrity Problem 4 4
Structural Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1708 1708
No Consequences Or Impact To Patient 342 342
Unspecified Tissue Injury 173 173
Tooth Fracture 134 134
No Known Impact Or Consequence To Patient 102 102
Pain 94 94
Laceration(s) 92 92
Hemorrhage/Bleeding 82 82
Foreign Body In Patient 80 80
Choking 76 76
Insufficient Information 70 70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 50 50
Injury 43 43
Burn(s) 22 22
Discomfort 20 20
No Patient Involvement 14 14
Electric Shock 11 11
Abrasion 9 9
Skin Inflammation/ Irritation 7 7
Device Embedded In Tissue or Plaque 6 6
Erosion 6 6
Cough 6 6
Swelling/ Edema 6 6
No Code Available 6 6
Patient Problem/Medical Problem 5 5
Sensitivity of Teeth 4 4
Tinnitus 4 4
Bruise/Contusion 3 3
Itching Sensation 3 3
Chemical Exposure 3 3
Superficial (First Degree) Burn 3 3
Vomiting 3 3
Dyspnea 3 3
Skin Discoloration 2 2
Irritation 2 2
Bone Fracture(s) 2 2
Tissue Damage 2 2
Caustic/Chemical Burns 2 2
Abdominal Pain 2 2
Scar Tissue 2 2
Stomatitis 1 1
Airway Obstruction 1 1
Headache 1 1
Hypoesthesia 1 1
Irritability 1 1
Sore Throat 1 1
Unspecified Infection 1 1
Skin Infection 1 1
Partial thickness (Second Degree) Burn 1 1
Anxiety 1 1

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