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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 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
Patient Device Interaction Problem 10 10
Fire 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
Material Fragmentation 3 3
Device Contamination with Chemical or Other Material 3 3
No Apparent Adverse Event 3 3
Insufficient Information 3 3
Noise, Audible 3 3
Circuit Failure 2 2
Sparking 2 2
Use of Device Problem 2 2
Device Emits Odor 2 2
Electrical Shorting 2 2
Melted 2 2
Nonstandard Device 2 2
Burst Container or Vessel 2 2
Thermal Decomposition of Device 1 1
Device Damaged by Another Device 1 1
Decrease in Pressure 1 1
Fail-Safe Problem 1 1
Smoking 1 1
Electrical Overstress 1 1
Failure to Clean Adequately 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Patient-Device Incompatibility 1 1
Split 1 1
Unintended Electrical Shock 1 1
Crack 1 1
Detachment Of Device Component 1 1
Improper or Incorrect Procedure or Method 1 1
Loose or Intermittent Connection 1 1
Human-Device Interface Problem 1 1
Fungus in Device Environment 1 1
Protective Measures Problem 1 1
Excessive Heating 1 1
Device Contamination With Biological Material 1 1
Increase in Pressure 1 1
Explosion 1 1
Product Quality Problem 1 1
Obstruction of Flow 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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