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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
PROCTER & GAMBLE CO.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K141018  ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, O ...
THE PROCTER & GAMBLE COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 125 125
2015 505 505
2016 517 517
2017 868 868
2018 743 743
2019 385 385
2020 433 433
2021 551 551
2022 611 611
2023 567 567
2024 242 242

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1993 1993
Detachment of Device or Device Component 899 899
Missing Value Reason 719 719
Detachment Of Device Component 655 655
No Apparent Adverse Event 485 485
Loose or Intermittent Connection 453 453
Insufficient Information 156 156
Patient Device Interaction Problem 146 146
Device Slipped 132 132
Component Falling 113 113
Mechanical Problem 100 100
Material Fragmentation 96 96
Material Separation 94 94
Overheating of Device 88 88
Connection Problem 76 76
Fire 73 73
Electrical /Electronic Property Problem 68 68
Device Fell 68 68
Temperature Problem 66 66
Adverse Event Without Identified Device or Use Problem 64 64
Appropriate Term/Code Not Available 50 50
Device Dislodged or Dislocated 42 42
Crack 39 39
Smoking 37 37
Device Operates Differently Than Expected 35 35
Naturally Worn 33 33
Vibration 30 30
Noise, Audible 29 29
Arcing 26 26
Product Quality Problem 26 26
Melted 26 26
Device Emits Odor 21 21
Defective Device 19 19
Material Integrity Problem 18 18
Material Protrusion/Extrusion 18 18
Explosion 17 17
Thermal Decomposition of Device 17 17
Material Disintegration 16 16
Fitting Problem 15 15
Burst Container or Vessel 14 14
Entrapment of Device 13 13
Component Missing 13 13
Disassembly 12 12
Sparking 12 12
Defective Component 11 11
Unintended Ejection 9 9
Sticking 9 9
Hole In Material 9 9
Output Problem 9 9
Scratched Material 9 9
Patient-Device Incompatibility 8 8
Degraded 8 8
Disconnection 7 7
Physical Property Issue 7 7
Unintended Movement 7 7
Separation Problem 7 7
Sharp Edges 6 6
Battery Problem 6 6
Use of Device Problem 6 6
Split 6 6
Charging Problem 6 6
Corroded 6 6
Leak/Splash 5 5
Microbial Contamination of Device 5 5
Device Inoperable 5 5
Unstable 5 5
Excessive Heating 5 5
Material Split, Cut or Torn 4 4
Mechanical Jam 4 4
Mechanics Altered 4 4
Material Deformation 4 4
Device Contamination with Chemical or Other Material 4 4
Improper or Incorrect Procedure or Method 4 4
Structural Problem 4 4
Failure to Align 4 4
Loss of Power 4 4
Fluid/Blood Leak 4 4
Fracture 4 4
Material Discolored 4 4
Failure to Cycle 3 3
Failure to Charge 3 3
Material Puncture/Hole 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Inadequacy of Device Shape and/or Size 3 3
Electrical Shorting 3 3
Malposition of Device 3 3
Physical Resistance/Sticking 3 3
Protective Measures Problem 3 3
Unintended Electrical Shock 2 2
Deformation Due to Compressive Stress 2 2
Contamination /Decontamination Problem 2 2
Expulsion 2 2
Flare or Flash 2 2
Positioning Problem 2 2
Nonstandard Device 2 2
Unintended Collision 2 2
Device Stops Intermittently 2 2
Contamination 2 2
Migration or Expulsion of Device 2 2
Misconnection 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1572 1572
No Consequences Or Impact To Patient 1198 1198
No Known Impact Or Consequence To Patient 832 832
Patient Problem/Medical Problem 454 454
Injury 296 296
Tooth Fracture 270 270
Pain 172 172
Foreign Body In Patient 169 169
Choking 163 163
Unspecified Tissue Injury 161 161
Laceration(s) 157 157
Hemorrhage/Bleeding 146 146
Insufficient Information 70 70
No Code Available 49 49
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Discomfort 37 37
No Information 33 33
Burn(s) 22 22
No Patient Involvement 20 20
Abrasion 19 19
Complaint, Ill-Defined 18 18
Swelling 17 17
Sensitivity of Teeth 17 17
Electric Shock 13 13
Unspecified Infection 10 10
Device Embedded In Tissue or Plaque 8 8
Skin Inflammation/ Irritation 7 7
Erosion 7 7
Bruise/Contusion 6 6
Dyspnea 6 6
Tissue Damage 6 6
Itching Sensation 6 6
Cough 6 6
Swelling/ Edema 5 5
Respiratory Distress 5 5
Burning Sensation 5 5
Physical Entrapment 5 5
Sore Throat 5 5
Reaction 4 4
Tinnitus 4 4
Erythema 4 4
Irritation 4 4
Perforation 4 4
Hypersensitivity/Allergic reaction 4 4
Chemical Exposure 4 4
Superficial (First Degree) Burn 4 4
Needle Stick/Puncture 4 4
Burn, Thermal 3 3
Inflammation 3 3
Eye Injury 3 3
Scar Tissue 3 3
Suffocation 3 3
Fungal Infection 3 3
Vomiting 3 3
Increased Sensitivity 2 2
Dizziness 2 2
Dysphasia 2 2
Contusion 2 2
Crushing Injury 2 2
Abscess 2 2
Airway Obstruction 2 2
Fever 2 2
Bone Fracture(s) 2 2
Headache 2 2
Caustic/Chemical Burns 2 2
Skin Tears 2 2
Blood Loss 2 2
Alteration In Body Temperature 1 1
Partial thickness (Second Degree) Burn 1 1
Sleep Dysfunction 1 1
Sweating 1 1
Increased Appetite 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
Hearing Impairment 1 1
Hearing Loss 1 1
Pyrosis/Heartburn 1 1
Head Injury 1 1
Abdominal Pain 1 1
Rash 1 1
Nausea 1 1
Undesired Nerve Stimulation 1 1
Angina 1 1
Aspiration/Inhalation 1 1
Asthma 1 1
Stroke/CVA 1 1
Diarrhea 1 1
Purulent Discharge 1 1
Dysphagia/ Odynophagia 1 1
Fall 1 1
Fatigue 1 1
Feeding Problem 1 1
Asphyxia 1 1
Twitching 1 1
Visual Impairment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Brushpoint Innovations, Inc. II Mar-18-2011
2 Church & Dwight Inc II Jan-25-2012
3 Ranir Corporation II Jan-17-2014
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