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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device balloon, epistaxis
Regulation Description Epistaxis balloon.
Product CodeEMX
Regulation Number 874.4100
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2018 3 3
2019 12 12
2020 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 6 6
Improper or Incorrect Procedure or Method 5 5
Material Rupture 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Break 2 2
Inflation Problem 1 1
Material Separation 1 1
Balloon 1 1
Decrease in Pressure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 9 9
Abrasion 5 5
Dyspnea 2 2
No Known Impact Or Consequence To Patient 2 2
Blood Loss 2 2
Hemorrhage/Bleeding 2 2
Pain 2 2
Respiratory Distress 1 1
Death 1 1
Foreign Body In Patient 1 1
No Code Available 1 1
Exsanguination 1 1
Perforation 1 1
Low Oxygen Saturation 1 1

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