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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
2020 5 5
2021 2 2
2023 3 3
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 7 7
Insufficient Information 5 5
Break 4 4
Material Discolored 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Split, Cut or Torn 1 1
Inflation Problem 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 10 10
Injury 4 4
Epistaxis 2 2
Vomiting 2 2
Hemorrhage/Bleeding 2 2
Perforation 1 1
Fever 1 1
Insufficient Information 1 1
Pain 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Cerebrospinal Fluid Leakage 1 1
Headache 1 1
Airway Obstruction 1 1

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