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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
otoscope
Product Code
ERA
Regulation Number
874.4770
Device Class
1
Premarket Reviews
Manufacturer
Decision
BLUE FOCUS
SUBSTANTIALLY EQUIVALENT
1
LANTOS TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
OSRAM SYLVANIA, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2019
1
1
2021
3
3
2022
3
3
2023
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
2
2
Smoking
2
2
Material Split, Cut or Torn
2
2
Sharp Edges
1
1
Thermal Decomposition of Device
1
1
Intermittent Continuity
1
1
Display or Visual Feedback Problem
1
1
Material Fragmentation
1
1
Melted
1
1
Poor Quality Image
1
1
Use of Device Problem
1
1
Battery Problem
1
1
Device Markings/Labelling Problem
1
1
Optical Discoloration
1
1
Temperature Problem
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
3
3
No Clinical Signs, Symptoms or Conditions
3
3
Superficial (First Degree) Burn
2
2
No Known Impact Or Consequence To Patient
1
1
Scar Tissue
1
1
Not Applicable
1
1
Blister
1
1
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