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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
2014 1 1
2016 1 1
2018 3 3
2019 12 12
2020 5 5
2021 2 2
2023 3 3
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 7 7
Break 6 6
Insufficient Information 6 6
Improper or Incorrect Procedure or Method 5 5
Adverse Event Without Identified Device or Use Problem 3 3
Material Rupture 3 3
Material Discolored 2 2
Inflation Problem 2 2
Air Leak 1 1
Decrease in Pressure 1 1
Material Separation 1 1

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

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