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TPLC
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Device
toothbrush, manual
Regulation Description
Manual toothbrush.
Product Code
EFW
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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