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TPLC
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show TPLC since
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Device
toothbrush, manual
Product Code
EFW
Regulation Number
872.6855
Device Class
1
Premarket Reviews
Manufacturer
Decision
BEAM TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
DENTEK ORAL CARE, INC.
SUBSTANTIALLY EQUIVALENT
1
PIAVE SPAZZOLIFICIO S.P.A.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
23
23
2015
48
48
2016
35
35
2017
68
68
2018
109
109
2019
115
115
2020
113
113
2021
120
120
2022
327
327
2023
99
99
2024
27
27
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
346
346
Break
324
324
Product Quality Problem
128
128
Detachment Of Device Component
84
84
Material Fragmentation
80
80
Material Separation
38
38
Component Falling
29
29
Adverse Event Without Identified Device or Use Problem
27
27
Device Slipped
23
23
Improper or Incorrect Procedure or Method
22
22
Device Fell
15
15
Entrapment of Device
13
13
Material Disintegration
10
10
Device Operates Differently Than Expected
10
10
Patient-Device Incompatibility
9
9
Sticking
8
8
Loose or Intermittent Connection
8
8
Insufficient Information
8
8
Defective Device
7
7
Material Integrity Problem
7
7
Difficult to Remove
6
6
Device Dislodged or Dislocated
6
6
Physical Resistance/Sticking
5
5
Material Twisted/Bent
4
4
Device Contamination with Chemical or Other Material
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Human-Device Interface Problem
2
2
Out-Of-Box Failure
2
2
Structural Problem
2
2
Material Too Rigid or Stiff
2
2
Fluid/Blood Leak
2
2
Mechanical Problem
2
2
Peeled/Delaminated
2
2
Bent
2
2
Material Protrusion/Extrusion
2
2
No Apparent Adverse Event
2
2
Appropriate Term/Code Not Available
2
2
Patient Device Interaction Problem
2
2
Unintended Electrical Shock
1
1
Naturally Worn
1
1
Output Problem
1
1
Packaging Problem
1
1
Protective Measures Problem
1
1
Unintended Ejection
1
1
Disassembly
1
1
Fracture
1
1
Device Damaged Prior to Use
1
1
Device Inoperable
1
1
Use of Device Problem
1
1
Metal Shedding Debris
1
1
Inadequate User Interface
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Deformation
1
1
Contamination /Decontamination Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
254
254
Insufficient Information
221
221
No Clinical Signs, Symptoms or Conditions
180
180
Foreign Body In Patient
103
103
Choking
89
89
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
55
55
Device Embedded In Tissue or Plaque
51
51
No Code Available
30
30
No Information
24
24
Pain
22
22
Discomfort
17
17
Vomiting
14
14
Swelling
11
11
Hemorrhage/Bleeding
11
11
Laceration(s)
9
9
Cough
9
9
No Consequences Or Impact To Patient
8
8
Injury
8
8
Hypersensitivity/Allergic reaction
6
6
Complaint, Ill-Defined
5
5
Reaction
5
5
Anxiety
4
4
Tooth Fracture
4
4
Inflammation
4
4
Irritation
4
4
Dyspnea
4
4
Tissue Damage
4
4
Burning Sensation
3
3
Rash
3
3
No Patient Involvement
3
3
Needle Stick/Puncture
3
3
Unspecified Tissue Injury
3
3
Unspecified Infection
3
3
Numbness
3
3
Sensitivity of Teeth
3
3
Sore Throat
2
2
Malaise
2
2
Unspecified Gastrointestinal Problem
2
2
Patient Problem/Medical Problem
2
2
Respiratory Distress
2
2
Emotional Changes
2
2
Abscess
2
2
Itching Sensation
2
2
High Blood Pressure/ Hypertension
1
1
Hemorrhage, Cerebral
1
1
Vessel Or Plaque, Device Embedded In
1
1
Abrasion
1
1
Achalasia
1
1
Airway Obstruction
1
1
Anaphylactic Shock
1
1
Asthma
1
1
Burn(s)
1
1
Erythema
1
1
Eye Injury
1
1
Foreign Body Sensation in Eye
1
1
Headache
1
1
Hemoptysis
1
1
Skin Discoloration
1
1
Suffocation
1
1
Nausea
1
1
Perforation
1
1
Tingling
1
1
Ulceration
1
1
Tachycardia
1
1
Thrombosis
1
1
Thrombus
1
1
Hypervolemia
1
1
Dysuria
1
1
Post Traumatic Wound Infection
1
1
Sleep Dysfunction
1
1
Chemical Exposure
1
1
Injection Site Reaction
1
1
Stomatitis
1
1
Depression
1
1
Pharyngitis
1
1
Anaphylactoid
1
1
Discharge
1
1
Collapse
1
1
Coma
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Family Dollar Stores, Llc.
II
Aug-17-2022
2
Fridababy LLC
II
Jan-30-2020
3
Norwex Usa Inc
II
Feb-26-2015
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