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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2021 3 4
2022 3 3
2023 3 3
2024 2 2
2025 2 2
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 2 2
Unintended Electrical Shock 2 2
Thermal Decomposition of Device 2 2
Fire 1 1
Poor Quality Image 1 1
Device Markings/Labelling Problem 1 1
Smoking 1 2
Battery Problem 1 2
Use of Device Problem 1 1
Sharp Edges 1 1
Device Emits Odor 1 1
Excessive Heating 1 1
Intermittent Continuity 1 1
Melted 1 2
Optical Discoloration 1 1
Overheating of Device 1 2
Display or Visual Feedback Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 3 3
Superficial (First Degree) Burn 2 2
Blister 1 2
Foreign Body In Patient 1 1
Scar Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jun-11-2025
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