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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device toothbrush, manual
Product CodeEFW
Regulation Number 872.6855
Device Class 1

MDR Year MDR Reports MDR Events
2019 115 115
2020 113 113
2021 120 120
2022 327 327
2023 99 99
2024 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 320 320
Break 225 225
Product Quality Problem 108 108
Material Fragmentation 68 68
Material Separation 33 33
Device Slipped 21 21
Adverse Event Without Identified Device or Use Problem 17 17
Improper or Incorrect Procedure or Method 16 16
Device Fell 13 13
Defective Device 7 7
Material Disintegration 5 5
Physical Resistance/Sticking 5 5
Entrapment of Device 4 4
Patient-Device Incompatibility 4 4
Material Twisted/Bent 4 4
Insufficient Information 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Loose or Intermittent Connection 3 3
Difficult to Remove 2 2
No Apparent Adverse Event 2 2
Patient Device Interaction Problem 2 2
Unintended Electrical Shock 1 1
Appropriate Term/Code Not Available 1 1
Naturally Worn 1 1
Material Too Rigid or Stiff 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Output Problem 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Mechanical Problem 1 1
Peeled/Delaminated 1 1
Fluid/Blood Leak 1 1
Contamination /Decontamination Problem 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequate User Interface 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 221 221
No Clinical Signs, Symptoms or Conditions 192 192
No Known Impact Or Consequence To Patient 123 123
Foreign Body In Patient 65 65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 56 56
Device Embedded In Tissue or Plaque 46 46
Choking 42 42
No Code Available 17 17
Pain 11 11
Laceration(s) 9 9
Cough 9 9
Discomfort 6 6
Swelling 5 5
No Information 5 5
Hemorrhage/Bleeding 4 4
Hypersensitivity/Allergic reaction 4 4
Vomiting 4 4
Inflammation 3 3
No Consequences Or Impact To Patient 3 3
Injury 3 3
Reaction 3 3
Numbness 3 3
Sensitivity of Teeth 3 3
Unspecified Tissue Injury 3 3
Unspecified Gastrointestinal Problem 2 2
Tooth Fracture 2 2
Needle Stick/Puncture 2 2
Anxiety 2 2
Burning Sensation 2 2
Emotional Changes 2 2
Abscess 2 2
Asthma 1 1
Burn(s) 1 1
Dyspnea 1 1
Eye Injury 1 1
Hemoptysis 1 1
Unspecified Infection 1 1
Tachycardia 1 1
Thrombosis 1 1
Thrombus 1 1
Ulceration 1 1
Rash 1 1
Skin Discoloration 1 1
Suffocation 1 1
Tingling 1 1
Itching Sensation 1 1
Complaint, Ill-Defined 1 1
Malaise 1 1
Depression 1 1
Post Traumatic Wound Infection 1 1
Injection Site Reaction 1 1
Stomatitis 1 1
Patient Problem/Medical Problem 1 1
Chemical Exposure 1 1
No Patient Involvement 1 1
Hypervolemia 1 1
Dysuria 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Aug-17-2022
2 Fridababy LLC II Jan-30-2020
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