TPLC - Total Product Life Cycle

• Device: agents, embolic, for treatment of uterine fibroids
• Product Code: NAJ
• Regulation Number: 870.3300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
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	29	29

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	8	8
Necrosis	7	7
Insufficient Information	6	6
Fever	5	5
Abdominal Pain	4	4
Hemorrhage/Bleeding	4	4
Fatigue	3	3
Nausea	3	3
Vomiting	3	3
Renal Failure	3	3
Unspecified Infection	2	2
Low Blood Pressure/ Hypotension	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Inflammation	2	2
Paralysis	2	2
Pulmonary Infarction	2	2
Bradycardia	2	2
Heart Failure/Congestive Heart Failure	2	2
Swelling/ Edema	2	2
Urinary Tract Infection	1	1
Fistula	1	1
Pulmonary Embolism	1	1
Decreased Appetite	1	1
Ischemia Stroke	1	1
Loss of Vision	1	1
Sexual Dysfunction	1	1
Cardiac Enzyme Elevation	1	1
Constipation	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
Urinary Retention	1	1
Thrombosis/Thrombus	1	1
Confusion/ Disorientation	1	1
Electrolyte Imbalance	1	1
Skin Inflammation/ Irritation	1	1
Hematuria	1	1
Dizziness	1	1
Sepsis	1	1
Hypersensitivity/Allergic reaction	1	1
Liver Damage/Dysfunction	1	1
Skin Infection	1	1
High Blood Pressure/ Hypertension	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Weight Changes	1	1