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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
heat source for bleaching teeth
Product Code
EEG
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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