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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
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 9 9
Temperature Problem 7 7
Patient Device Interaction Problem 7 7
Mechanical Problem 5 5
Appropriate Term/Code Not Available 5 5
Detachment of Device or Device Component 4 4
Noise, Audible 3 3
Break 3 3
Material Fragmentation 3 3
No Apparent Adverse Event 3 3
Circuit Failure 2 2
Sparking 2 2
Nonstandard Device 2 2
Electrical Shorting 2 2
Human-Device Interface Problem 1 1
Fungus in Device Environment 1 1
Melted 1 1
Excessive Heating 1 1
Product Quality Problem 1 1
Device Emits Odor 1 1
Explosion 1 1
Device Contamination with Chemical or Other Material 1 1
Decrease in Pressure 1 1
Thermal Decomposition of Device 1 1
Device Damaged by Another Device 1 1
Obstruction of Flow 1 1
Flare or Flash 1 1
Use of Device Problem 1 1
Failure to Power Up 1 1
Fail-Safe Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Failure to Clean Adequately 1 1
Material Integrity Problem 1 1
Smoking 1 1
Electrical Overstress 1 1
Insufficient Information 1 1
Device Fell 1 1
Unintended Electrical Shock 1 1
Burst Container or Vessel 1 1
Pressure Problem 1 1
Failure to Charge 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 61 61
Tooth Fracture 11 11
Insufficient Information 9 9
No Consequences Or Impact To Patient 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Failure of Implant 3 3
No Known Impact Or Consequence To Patient 3 3
Sensitivity of Teeth 3 3
Superficial (First Degree) Burn 2 2
Electric Shock 2 2
No Code Available 2 2
Skin Inflammation/ Irritation 2 2
Burn(s) 2 2
Unspecified Tissue Injury 2 2
Erosion 2 2
Inflammation 1 1
Blister 1 1
Rash 1 1
Foreign Body In Patient 1 1
Abscess 1 1
Eye Pain 1 1
Sore Throat 1 1

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