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TPLC
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Device
toothbrush, powered
Product Code
JEQ
Regulation Number
872.6865
Device Class
1
Premarket Reviews
Manufacturer
Decision
PROCTER & GAMBLE CO.
SUBSTANTIALLY EQUIVALENT
1
THE PROCTER & GAMBLE COMPANY
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
125
125
2015
505
505
2016
517
517
2017
868
868
2018
743
743
2019
385
385
2020
433
433
2021
551
551
2022
611
611
2023
567
567
2024
242
242
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1993
1993
Detachment of Device or Device Component
899
899
Missing Value Reason
719
719
Detachment Of Device Component
655
655
No Apparent Adverse Event
485
485
Loose or Intermittent Connection
453
453
Insufficient Information
156
156
Patient Device Interaction Problem
146
146
Device Slipped
132
132
Component Falling
113
113
Mechanical Problem
100
100
Material Fragmentation
96
96
Material Separation
94
94
Overheating of Device
88
88
Connection Problem
76
76
Fire
73
73
Electrical /Electronic Property Problem
68
68
Device Fell
68
68
Temperature Problem
66
66
Adverse Event Without Identified Device or Use Problem
64
64
Appropriate Term/Code Not Available
50
50
Device Dislodged or Dislocated
42
42
Crack
39
39
Smoking
37
37
Device Operates Differently Than Expected
35
35
Naturally Worn
33
33
Vibration
30
30
Noise, Audible
29
29
Arcing
26
26
Product Quality Problem
26
26
Melted
26
26
Device Emits Odor
21
21
Defective Device
19
19
Material Integrity Problem
18
18
Material Protrusion/Extrusion
18
18
Explosion
17
17
Thermal Decomposition of Device
17
17
Material Disintegration
16
16
Fitting Problem
15
15
Burst Container or Vessel
14
14
Entrapment of Device
13
13
Component Missing
13
13
Disassembly
12
12
Sparking
12
12
Defective Component
11
11
Unintended Ejection
9
9
Sticking
9
9
Hole In Material
9
9
Output Problem
9
9
Scratched Material
9
9
Patient-Device Incompatibility
8
8
Degraded
8
8
Disconnection
7
7
Physical Property Issue
7
7
Unintended Movement
7
7
Separation Problem
7
7
Sharp Edges
6
6
Battery Problem
6
6
Use of Device Problem
6
6
Split
6
6
Charging Problem
6
6
Corroded
6
6
Leak/Splash
5
5
Microbial Contamination of Device
5
5
Device Inoperable
5
5
Unstable
5
5
Excessive Heating
5
5
Material Split, Cut or Torn
4
4
Mechanical Jam
4
4
Mechanics Altered
4
4
Material Deformation
4
4
Device Contamination with Chemical or Other Material
4
4
Improper or Incorrect Procedure or Method
4
4
Structural Problem
4
4
Failure to Align
4
4
Loss of Power
4
4
Fluid/Blood Leak
4
4
Fracture
4
4
Material Discolored
4
4
Failure to Cycle
3
3
Failure to Charge
3
3
Material Puncture/Hole
3
3
Inappropriate/Inadequate Shock/Stimulation
3
3
Inadequacy of Device Shape and/or Size
3
3
Electrical Shorting
3
3
Malposition of Device
3
3
Physical Resistance/Sticking
3
3
Protective Measures Problem
3
3
Unintended Electrical Shock
2
2
Deformation Due to Compressive Stress
2
2
Contamination /Decontamination Problem
2
2
Expulsion
2
2
Flare or Flash
2
2
Positioning Problem
2
2
Nonstandard Device
2
2
Unintended Collision
2
2
Device Stops Intermittently
2
2
Contamination
2
2
Migration or Expulsion of Device
2
2
Misconnection
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1572
1572
No Consequences Or Impact To Patient
1198
1198
No Known Impact Or Consequence To Patient
832
832
Patient Problem/Medical Problem
454
454
Injury
296
296
Tooth Fracture
270
270
Pain
172
172
Foreign Body In Patient
169
169
Choking
163
163
Unspecified Tissue Injury
161
161
Laceration(s)
157
157
Hemorrhage/Bleeding
146
146
Insufficient Information
70
70
No Code Available
49
49
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
42
42
Discomfort
37
37
No Information
33
33
Burn(s)
22
22
No Patient Involvement
20
20
Abrasion
19
19
Complaint, Ill-Defined
18
18
Swelling
17
17
Sensitivity of Teeth
17
17
Electric Shock
13
13
Unspecified Infection
10
10
Device Embedded In Tissue or Plaque
8
8
Skin Inflammation/ Irritation
7
7
Erosion
7
7
Bruise/Contusion
6
6
Dyspnea
6
6
Tissue Damage
6
6
Itching Sensation
6
6
Cough
6
6
Swelling/ Edema
5
5
Respiratory Distress
5
5
Burning Sensation
5
5
Physical Entrapment
5
5
Sore Throat
5
5
Reaction
4
4
Tinnitus
4
4
Erythema
4
4
Irritation
4
4
Perforation
4
4
Hypersensitivity/Allergic reaction
4
4
Chemical Exposure
4
4
Superficial (First Degree) Burn
4
4
Needle Stick/Puncture
4
4
Burn, Thermal
3
3
Inflammation
3
3
Eye Injury
3
3
Scar Tissue
3
3
Suffocation
3
3
Fungal Infection
3
3
Vomiting
3
3
Increased Sensitivity
2
2
Dizziness
2
2
Dysphasia
2
2
Contusion
2
2
Crushing Injury
2
2
Abscess
2
2
Airway Obstruction
2
2
Fever
2
2
Bone Fracture(s)
2
2
Headache
2
2
Caustic/Chemical Burns
2
2
Skin Tears
2
2
Blood Loss
2
2
Alteration In Body Temperature
1
1
Partial thickness (Second Degree) Burn
1
1
Sleep Dysfunction
1
1
Sweating
1
1
Increased Appetite
1
1
Unspecified Eye / Vision Problem
1
1
Hematemesis
1
1
Stomatitis
1
1
Skin Disorders
1
1
Skin Infection
1
1
Paresthesia
1
1
Foreign Body Embolism
1
1
Hearing Impairment
1
1
Hearing Loss
1
1
Pyrosis/Heartburn
1
1
Head Injury
1
1
Abdominal Pain
1
1
Rash
1
1
Nausea
1
1
Undesired Nerve Stimulation
1
1
Angina
1
1
Aspiration/Inhalation
1
1
Asthma
1
1
Stroke/CVA
1
1
Diarrhea
1
1
Purulent Discharge
1
1
Dysphagia/ Odynophagia
1
1
Fall
1
1
Fatigue
1
1
Feeding Problem
1
1
Asphyxia
1
1
Twitching
1
1
Visual Impairment
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Brushpoint Innovations, Inc.
II
Mar-18-2011
2
Church & Dwight Inc
II
Jan-25-2012
3
Ranir Corporation
II
Jan-17-2014
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