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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device balloon, epistaxis
Product CodeEMX
Regulation Number 874.4100
Device Class 1


Premarket Reviews
ManufacturerDecision
HEMOSTASIS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 3 3
2019 12 12
2020 5 5
2021 2 2
2023 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 9 9
Abrasion 5 5
Pain 3 3
Dyspnea 2 2
Blood Loss 2 2
Hemorrhage/Bleeding 2 2
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Exsanguination 1 1
Fever 1 1
Death 1 1
Perforation 1 1
Respiratory Distress 1 1
Low Oxygen Saturation 1 1

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