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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


Premarket Reviews
ManufacturerDecision
HEMOSTASIS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 2 2
2023 3 3
2024 12 12
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Detachment of Device or Device Component 9 9
Break 5 5
Insufficient Information 5 5
Material Split, Cut or Torn 2 2
Material Disintegration 2 2
Material Discolored 2 2
Inflation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Migration 1 1
Device Dislodged or Dislocated 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Epistaxis 5 5
Injury 4 4
Hemorrhage/Bleeding 4 4
Perforation 3 3
High Blood Pressure/ Hypertension 2 2
Vomiting 2 2
Airway Obstruction 2 2
Anemia 1 1
Fever 1 1
Insufficient Information 1 1
Pain 1 1
Scar Tissue 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Cerebrospinal Fluid Leakage 1 1
Headache 1 1

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