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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heat source for bleaching teeth
Product CodeEEG
Regulation Number 872.6475
Device Class 1

MDR Year MDR Reports MDR Events
2017 10 10
2018 6 6
2019 3 3
2020 6 6
2021 6 6
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 26 26
Improper or Incorrect Procedure or Method 3 3
Patient Device Interaction Problem 2 2
Unintended Electrical Shock 2 2
Inadequate Instructions for Non-Healthcare Professional 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Smoking 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sensitivity of Teeth 7 7
Reaction 5 5
Burn(s) 5 5
Patient Problem/Medical Problem 5 5
No Clinical Signs, Symptoms or Conditions 3 3
Pain 3 3
Tooth Fracture 3 3
Burning Sensation 2 2
Swelling 2 2
Caustic/Chemical Burns 2 2
Electric Shock 1 1
Blister 1 1
Swelling/ Edema 1 1
Tissue Damage 1 1
Vomiting 1 1
Red Eye(s) 1 1
Erythema 1 1
Hypersensitivity/Allergic reaction 1 1
Nausea 1 1
Dysphasia 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Burn, Thermal 1 1
Numbness 1 1

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