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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
Regulation Description Oral irrigation unit.
Product CodeEFS
Regulation Number 872.6510
Device Class 1

MDR Year MDR Reports MDR Events
2021 18 18
2022 21 21
2023 34 34
2024 31 31
2025 9 9
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 28 28
Overheating of Device 20 20
Temperature Problem 10 10
Fire 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Mechanical Problem 5 5
Detachment of Device or Device Component 4 4
Appropriate Term/Code Not Available 4 4
Material Fragmentation 3 3
No Apparent Adverse Event 3 3
Sparking 2 2
Break 2 2
Patient Device Interaction Problem 2 2
Electrical Shorting 2 2
Circuit Failure 1 1
Pressure Problem 1 1
Burst Container or Vessel 1 1
Unintended Electrical Shock 1 1
Insufficient Information 1 1
Smoking 1 1
Electrical Overstress 1 1
Material Integrity Problem 1 1
Failure to Clean Adequately 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Fail-Safe Problem 1 1
Use of Device Problem 1 1
Obstruction of Flow 1 1
Flare or Flash 1 1
Thermal Decomposition of Device 1 1
Decrease in Pressure 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1
Explosion 1 1
Excessive Heating 1 1
Melted 1 1
Nonstandard Device 1 1
Fungus in Device Environment 1 1
Human-Device Interface Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 73 73
Insufficient Information 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Electric Shock 3 3
Failure of Implant 3 3
Tooth Fracture 3 3
Superficial (First Degree) Burn 2 2
Skin Inflammation/ Irritation 2 2
Burn(s) 2 2
Unspecified Tissue Injury 2 2
No Consequences Or Impact To Patient 2 2
Erosion 2 2
Sensitivity of Teeth 2 2
Sepsis 1 1
Inflammation 1 1
Implant Pain 1 1
Blister 1 1
Rash 1 1
Foreign Body In Patient 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Nerve Damage 1 1
Discomfort 1 1
Abscess 1 1
Eye Pain 1 1
Sore Throat 1 1
Bacterial Infection 1 1

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