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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, tracheal
Product CodeKCG
Regulation Number 874.4420
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2016 1 1
2017 1 1
2018 2 2
2019 1 1
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Other (for use when an appropriate device code cannot be identified) 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Malposition of Device 1 1
Break 1 1
Device Operates Differently Than Expected 1 1
Insufficient Information 1 1
Detachment of Device or Device Component 1 1
Deformation Due to Compressive Stress 1 1
Material Twisted/Bent 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 3 3
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
No Code Available 1 1
No Information 1 1
Insufficient Information 1 1
Surgical procedure, additional 1 1
Hemorrhage/Bleeding 1 1

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