• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 276 276

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 722 722
Break 646 646
No Apparent Adverse Event 505 505
Loose or Intermittent Connection 255 255
Insufficient Information 140 140
Patient Device Interaction Problem 113 113
Mechanical Problem 97 97
Device Slipped 94 94
Overheating of Device 79 79
Material Fragmentation 79 79
Electrical /Electronic Property Problem 67 67
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 18 18
Product Quality Problem 17 17
Device Dislodged or Dislocated 16 16
Explosion 16 16
Noise, Audible 13 13
Crack 13 13
Thermal Decomposition of Device 11 11
Device Emits Odor 11 11
Vibration 10 10
Fitting Problem 9 9
Defective Device 9 9
Sparking 9 9
Output Problem 9 9
Melted 8 8
Degraded 8 8
Separation Problem 7 7
Appropriate Term/Code Not Available 7 7
Sharp Edges 6 6
Burst Container or Vessel 6 6
Material Protrusion/Extrusion 5 5
Battery Problem 5 5
Charging Problem 5 5
Component Missing 5 5
Excessive Heating 5 5
Material Split, Cut or Torn 4 4
Structural Problem 4 4
Unstable 4 4
Patient-Device Incompatibility 4 4
Material Integrity Problem 4 4
Material Disintegration 4 4
Loss of Power 4 4
Leak/Splash 4 4
Inadequacy of Device Shape and/or Size 3 3
Material Puncture/Hole 3 3
Entrapment of Device 3 3
Fluid/Blood Leak 3 3
Failure to Charge 3 3
Material Discolored 3 3
Disconnection 3 3
Failure to Cycle 3 3
Material Deformation 3 3
Electrical Shorting 3 3
Use of Device Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Failure to Align 3 3
Defective Component 3 3
Physical Resistance/Sticking 3 3
Scratched Material 3 3
Unintended Electrical Shock 2 2
Microbial Contamination of Device 2 2
Contamination /Decontamination Problem 2 2
Deformation Due to Compressive Stress 2 2
Mechanics Altered 2 2
Fracture 2 2
Corroded 2 2
Migration or Expulsion of Device 2 2
Misconnection 2 2
Nonstandard Device 1 1
Energy Output Problem 1 1
Stretched 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Material Erosion 1 1
Material Frayed 1 1
Contamination 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Positioning Problem 1 1
Flare or Flash 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Battery Problem: Low Impedance 1 1
Electrical Overstress 1 1
Computer System Security Problem 1 1
Delayed Charge Time 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1601 1601
No Consequences Or Impact To Patient 342 342
Unspecified Tissue Injury 162 162
Tooth Fracture 133 133
No Known Impact Or Consequence To Patient 102 102
Laceration(s) 91 91
Pain 89 89
Hemorrhage/Bleeding 80 80
Foreign Body In Patient 80 80
Choking 76 76
Insufficient Information 70 70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 44 44
Injury 43 43
Burn(s) 20 20
Discomfort 17 17
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
Cough 6 6
Erosion 6 6
Patient Problem/Medical Problem 5 5
Swelling/ Edema 5 5
Sensitivity of Teeth 4 4
Tinnitus 4 4
Vomiting 3 3
Bruise/Contusion 3 3
Dyspnea 3 3
Superficial (First Degree) Burn 3 3
Chemical Exposure 3 3
Caustic/Chemical Burns 2 2
Irritation 2 2
Itching Sensation 2 2
Tissue Damage 2 2
Scar Tissue 2 2
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
Laceration(s) of Esophagus 1 1
Respiratory Tract Infection 1 1
Irritability 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Infection 1 1
Inflammation 1 1
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
Increased Appetite 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

-
-