Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
toothbrush, manual
Regulation Description
Manual toothbrush.
Product Code
EFW
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
-
-