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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
unit, oral irrigation
Product Code
EFS
Regulation Number
872.6510
Device Class
1
MDR Year
MDR Reports
MDR Events
2015
7
7
2016
5
5
2017
7
7
2018
13
13
2019
6
6
2020
16
16
2021
18
18
2022
21
21
2023
34
34
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Electrical /Electronic Property Problem
19
19
Overheating of Device
11
11
Fire
10
10
Adverse Event Without Identified Device or Use Problem
10
10
Patient Device Interaction Problem
10
10
Temperature Problem
8
8
Missing Value Reason
7
7
Mechanical Problem
5
5
Break
4
4
Detachment of Device or Device Component
4
4
Appropriate Term/Code Not Available
4
4
Device Operates Differently Than Expected
4
4
Device Contamination with Chemical or Other Material
3
3
Insufficient Information
3
3
Noise, Audible
3
3
Material Fragmentation
3
3
Melted
2
2
Nonstandard Device
2
2
Device Emits Odor
2
2
Burst Container or Vessel
2
2
Circuit Failure
2
2
Sparking
2
2
Electrical Shorting
2
2
Use of Device Problem
2
2
No Apparent Adverse Event
2
2
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Explosion
1
1
Device Fell
1
1
Unintended Electrical Shock
1
1
Failure to Clean Adequately
1
1
Human-Device Interface Problem
1
1
Improper Device Output
1
1
Material Integrity Problem
1
1
Device Damaged by Another Device
1
1
Electrical Overstress
1
1
Pressure Problem
1
1
Protective Measures Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Fungus in Device Environment
1
1
Obstruction of Flow
1
1
Split
1
1
Failure to Power Up
1
1
Decrease in Pressure
1
1
Increase in Pressure
1
1
Product Quality Problem
1
1
Smoking
1
1
Expulsion
1
1
Fail-Safe Problem
1
1
Flare or Flash
1
1
Patient-Device Incompatibility
1
1
Device Contamination With Biological Material
1
1
Detachment Of Device Component
1
1
Crack
1
1
Material Discolored
1
1
Failure to Charge
1
1
Thermal Decomposition of Device
1
1
Moisture Damage
1
1
Leak/Splash
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
46
46
Tooth Fracture
15
15
Insufficient Information
9
9
Patient Problem/Medical Problem
9
9
No Consequences Or Impact To Patient
8
8
No Known Impact Or Consequence To Patient
8
8
Sensitivity of Teeth
5
5
Failure of Implant
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Injury
4
4
No Code Available
3
3
Unspecified Tissue Injury
2
2
Inflammation
2
2
Burn(s)
2
2
Superficial (First Degree) Burn
2
2
Abscess
2
2
Erosion
2
2
Electric Shock
2
2
Skin Inflammation/ Irritation
2
2
Bacterial Infection
1
1
No Information
1
1
Tinnitus
1
1
Irritation
1
1
Rash
1
1
Pain
1
1
Blister
1
1
No Patient Involvement
1
1
Sore Throat
1
1
Eye Injury
1
1
Eye Pain
1
1
Laceration(s)
1
1
Abrasion
1
1
Swelling
1
1
Foreign Body In Patient
1
1
-
-