Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
agents, embolic, for treatment of uterine fibroids
Product Code
NAJ
Regulation Number
870.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
CELONOVA BIOSCIENCES, INC.
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
SUZHOU HENGRUI CALLISYN BIOMEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
15
15
2015
16
16
2016
14
14
2017
11
11
2018
7
7
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
65
65
Insufficient Information
8
8
Therapy Delivered to Incorrect Body Area
8
8
Device Contamination with Chemical or Other Material
4
4
Migration or Expulsion of Device
3
3
Failure to Infuse
2
2
Failure to Deliver
2
2
Packaging Problem
1
1
Missing Value Reason
1
1
Device Damaged Prior to Use
1
1
Unsealed Device Packaging
1
1
Use of Device Problem
1
1
Device Packaging Compromised
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
19
19
Unspecified Infection
10
10
Fever
10
10
Necrosis
9
9
Abdominal Pain
6
6
Insufficient Information
6
6
Sudden Cardiac Death
6
6
Blood Loss
6
6
No Patient Involvement
5
5
Abscess
4
4
Vomiting
4
4
Renal Failure
4
4
Nausea
4
4
Inflammation
4
4
Obstruction/Occlusion
4
4
Hemorrhage/Bleeding
4
4
Death
3
3
Fatigue
3
3
No Consequences Or Impact To Patient
3
3
No Known Impact Or Consequence To Patient
3
3
Fibrosis
3
3
Disseminated Intravascular Coagulation (DIC)
2
2
Bradycardia
2
2
Heart Failure/Congestive Heart Failure
2
2
Pulmonary Edema
2
2
Swelling/ Edema
2
2
Pulmonary Infarction
2
2
Paralysis
2
2
Rash
2
2
Chills
2
2
Burning Sensation
2
2
Abnormal Vaginal Discharge
2
2
No Information
2
2
No Clinical Signs, Symptoms or Conditions
2
2
Not Applicable
2
2
Sepsis
2
2
Liver Damage/Dysfunction
2
2
Hypersensitivity/Allergic reaction
2
2
Low Blood Pressure/ Hypotension
2
2
Fistula
2
2
Urinary Tract Infection
2
2
Pulmonary Embolism
2
2
Headache
1
1
Cancer
1
1
Bacterial Infection
1
1
Constipation
1
1
Cardiac Enzyme Elevation
1
1
Sexual Dysfunction
1
1
Loss of Vision
1
1
Unspecified Heart Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Sep-15-2009
-
-