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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device agents, embolic, for treatment of uterine fibroids
Product CodeNAJ
Regulation Number 870.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 1 1
2021 4 4
2022 20 20
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 31 31
Failure to Deliver 2 2
Failure to Infuse 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8 8
Necrosis 7 7
Insufficient Information 6 6
Abdominal Pain 5 5
Fever 5 5
Nausea 4 4
Hemorrhage/Bleeding 4 4
Vomiting 4 4
Unspecified Infection 3 3
Fatigue 3 3
Inflammation 3 3
Renal Failure 3 3
Low Blood Pressure/ Hypotension 2 2
No Clinical Signs, Symptoms or Conditions 2 2
No Consequences Or Impact To Patient 2 2
Paralysis 2 2
Pulmonary Infarction 2 2
Swelling/ Edema 2 2
Heart Failure/Congestive Heart Failure 2 2
Bradycardia 2 2
Decreased Appetite 1 1
Urinary Tract Infection 1 1
Fistula 1 1
Pulmonary Embolism 1 1
Ischemia Stroke 1 1
Sexual Dysfunction 1 1
Constipation 1 1
Loss of Vision 1 1
Cardiac Enzyme Elevation 1 1
Unspecified Heart Problem 1 1
Cerebrospinal Fluid Leakage 1 1
Unspecified Tissue Injury 1 1
Pulmonary Edema 1 1
Prolapse 1 1
Dehydration 1 1
Discomfort 1 1
Urinary Retention 1 1
Diarrhea 1 1
Thrombosis/Thrombus 1 1
Chills 1 1
Burning Sensation 1 1
Weakness 1 1
Confusion/ Disorientation 1 1
Electrolyte Imbalance 1 1
Skin Inflammation/ Irritation 1 1
Hematuria 1 1
Dizziness 1 1
Sepsis 1 1
Liver Damage/Dysfunction 1 1
Hypersensitivity/Allergic reaction 1 1

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