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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, oral irrigation
Product CodeEFS
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
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
Sensitivity of Teeth 5 5
Injury 4 4
Failure of Implant 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 3 3
Electric Shock 2 2
Superficial (First Degree) Burn 2 2
Skin Inflammation/ Irritation 2 2
Unspecified Tissue Injury 2 2
Inflammation 2 2
Abscess 2 2
Erosion 2 2
Burn(s) 2 2
Eye Injury 1 1
Bacterial Infection 1 1
Sore Throat 1 1
Abrasion 1 1
Irritation 1 1
Laceration(s) 1 1
Pain 1 1
Rash 1 1
Swelling 1 1
Tinnitus 1 1
Foreign Body In Patient 1 1
No Patient Involvement 1 1
Eye Pain 1 1
Blister 1 1
No Information 1 1

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