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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device otoscope
Product CodeERA
Regulation Number 874.4770
Device Class 1


Premarket Reviews
ManufacturerDecision
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
Not Applicable 1 1
Blister 1 1
Scar Tissue 1 1

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