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TPLC
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show TPLC since
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2024
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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
25
25
Device Problems
MDRs with this Device Problem
Events in those MDRs
Electrical /Electronic Property Problem
26
26
Overheating of Device
18
18
Adverse Event Without Identified Device or Use Problem
10
10
Fire
10
10
Patient Device Interaction Problem
10
10
Temperature Problem
8
8
Missing Value Reason
7
7
Appropriate Term/Code Not Available
5
5
Mechanical Problem
5
5
Detachment of Device or Device Component
4
4
Device Operates Differently Than Expected
4
4
Break
4
4
No Apparent Adverse Event
3
3
Device Contamination with Chemical or Other Material
3
3
Material Fragmentation
3
3
Noise, Audible
3
3
Insufficient Information
3
3
Circuit Failure
2
2
Electrical Shorting
2
2
Sparking
2
2
Device Emits Odor
2
2
Use of Device Problem
2
2
Burst Container or Vessel
2
2
Nonstandard Device
2
2
Melted
2
2
Product Quality Problem
1
1
Explosion
1
1
Device Damaged by Another Device
1
1
Thermal Decomposition of Device
1
1
Decrease in Pressure
1
1
Fail-Safe Problem
1
1
Detachment Of Device Component
1
1
Loose or Intermittent Connection
1
1
Improper or Incorrect Procedure or Method
1
1
Human-Device Interface Problem
1
1
Fungus in Device Environment
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Moisture Damage
1
1
Device Fell
1
1
Patient-Device Incompatibility
1
1
Device Contamination With Biological Material
1
1
Excessive Heating
1
1
Increase in Pressure
1
1
Protective Measures Problem
1
1
Failure to Power Up
1
1
Flare or Flash
1
1
Obstruction of Flow
1
1
Material Discolored
1
1
Failure to Clean Adequately
1
1
Material Integrity Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
61
61
Tooth Fracture
16
16
Patient Problem/Medical Problem
9
9
Insufficient Information
9
9
No Known Impact Or Consequence To Patient
8
8
No Consequences Or Impact To Patient
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Sensitivity of Teeth
5
5
Failure of Implant
4
4
Injury
4
4
No Code Available
3
3
Superficial (First Degree) Burn
2
2
Electric Shock
2
2
Skin Inflammation/ Irritation
2
2
Inflammation
2
2
Burn(s)
2
2
Abscess
2
2
Unspecified Tissue Injury
2
2
Erosion
2
2
No Information
1
1
Abrasion
1
1
Blister
1
1
Irritation
1
1
Rash
1
1
Foreign Body In Patient
1
1
No Patient Involvement
1
1
Swelling
1
1
Pain
1
1
Laceration(s)
1
1
Eye Injury
1
1
Bacterial Infection
1
1
Tinnitus
1
1
Eye Pain
1
1
Sore Throat
1
1
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