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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device toothbrush, manual
Regulation Description Manual toothbrush.
Product CodeEFW
Regulation Number 872.6855
Device Class 1

MDR Year MDR Reports MDR Events
2020 113 113
2021 120 120
2022 327 327
2023 99 99
2024 89 89
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 312 312
Break 197 197
Product Quality Problem 105 105
Material Fragmentation 55 55
Material Separation 33 33
Device Slipped 18 18
Improper or Incorrect Procedure or Method 16 16
Adverse Event Without Identified Device or Use Problem 15 15
Defective Device 7 7
Insufficient Information 6 6
Entrapment of Device 3 3
Material Disintegration 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Physical Resistance/Sticking 2 2
Patient Device Interaction Problem 2 2
No Apparent Adverse Event 2 2
Loose or Intermittent Connection 2 2
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Problem 1 1
Output Problem 1 1
Peeled/Delaminated 1 1
Unintended Electrical Shock 1 1
Patient-Device Incompatibility 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Packaging Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Naturally Worn 1 1
Fluid/Blood Leak 1 1
Inadequate User Interface 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 244 244
Insufficient Information 222 222
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 61 61
Foreign Body In Patient 59 59
No Known Impact Or Consequence To Patient 48 48
Device Embedded In Tissue or Plaque 47 47
Choking 35 35
No Code Available 10 10
Cough 9 9
Laceration(s) 9 9
Pain 8 8
Discomfort 5 5
Hemorrhage/Bleeding 3 3
Unspecified Tissue Injury 3 3
Numbness 3 3
Hypersensitivity/Allergic reaction 2 2
Unspecified Gastrointestinal Problem 2 2
Inflammation 2 2
Anxiety 2 2
Tooth Fracture 2 2
Chemical Exposure 2 2
Vomiting 2 2
Hypervolemia 1 1
Stomatitis 1 1
Sensitivity of Teeth 1 1
Reaction 1 1
Dyspnea 1 1
No Patient Involvement 1 1
Depression 1 1
Swelling 1 1
Needle Stick/Puncture 1 1
Rash 1 1
Burn(s) 1 1
Post Traumatic Wound Infection 1 1
Foreign Body Reaction 1 1
Asthma 1 1
Malaise 1 1
Hemoptysis 1 1
Dysuria 1 1
Emotional Changes 1 1
Tingling 1 1
Injection Site Reaction 1 1
Patient Problem/Medical Problem 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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