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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
2021 120 120
2022 327 331
2023 99 99
2024 87 87
2025 71 71
2026 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 308 308
Break 206 206
Product Quality Problem 73 73
Material Separation 41 41
Adverse Event Without Identified Device or Use Problem 10 10
Insufficient Device Problem Information 7 7
Defective Device 4 4
Material Integrity Problem 4 4
Manufacturing, Packaging or Shipping Problem 2 2
Use of Device Problem 2 2
Separation Problem 1 1
Mechanical Problem 1 1
Off-Label Use 1 1
Material Fragmentation 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Loose or Intermittent Connection 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 335 335
Insufficient Information 200 204
Foreign Body In Patient 53 53
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 53 53
Device Embedded In Tissue or Plaque 47 47
Choking 34 34
Pain 11 11
Laceration(s) 10 10
Cough 9 9
Tooth Fracture 7 7
Unspecified Tissue Injury 4 4
Chemical Exposure 3 3
Discomfort 3 3
Hemorrhage/Blood Loss/Bleeding 3 3
Unspecified Gastrointestinal Problem 2 2
Inflammation 2 2
Vomiting 2 2
Numbness 2 2
Anxiety 2 2
Sore Throat 2 2
Unspecified Infection 1 1
Injection Site Reaction 1 1
Hypersensitivity/Allergic reaction 1 1
Emotional Changes 1 1
Dysuria 1 1
Hemoptysis 1 1
Malaise 1 1
Asthma 1 1
Foreign Body Reaction 1 1
Burn(s) 1 1
Wound Infection 1 1
Needle Stick/Puncture 1 1
Upper Respiratory Tract Injury 1 1
Depression 1 1
Dyspnea 1 1
Ulcer 1 1
Stomatitis 1 1
Hypervolemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Aug-17-2022
2 GOLD STAR DISTRIBUTION INC II Jan-27-2026
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