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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
stylet for catheter, gastro-urology
Regulation Description
Urological catheter and accessories.
Product Code
EZB
Regulation Number
876.5130
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
65
65
2021
69
69
2022
103
103
2023
179
179
2024
133
133
2025
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Flaked
145
145
Detachment of Device or Device Component
113
113
Adverse Event Without Identified Device or Use Problem
103
103
Break
71
71
Material Fragmentation
48
48
Peeled/Delaminated
38
38
Material Protrusion/Extrusion
27
27
Unraveled Material
23
23
Difficult to Advance
19
19
Improper Chemical Reaction
18
18
Material Twisted/Bent
15
15
Material Integrity Problem
13
13
Difficult to Insert
11
11
Material Deformation
11
11
Entrapment of Device
10
10
Device-Device Incompatibility
9
9
Device Contamination with Chemical or Other Material
8
8
Use of Device Problem
7
7
Difficult to Remove
7
7
Tear, Rip or Hole in Device Packaging
6
6
Device Damaged by Another Device
6
6
Inadequacy of Device Shape and/or Size
6
6
Device Handling Problem
5
5
Missing Information
5
5
Sharp Edges
4
4
Material Too Rigid or Stiff
4
4
Deformation Due to Compressive Stress
4
4
Accessory Incompatible
4
4
Incorrect Measurement
3
3
Unsealed Device Packaging
3
3
Appropriate Term/Code Not Available
3
3
Material Separation
3
3
Component Misassembled
2
2
Device Contaminated During Manufacture or Shipping
2
2
Nonstandard Device
2
2
Patient Device Interaction Problem
2
2
Contamination /Decontamination Problem
2
2
Defective Device
2
2
Fitting Problem
1
1
Biocompatibility
1
1
Positioning Failure
1
1
Failure to Unfold or Unwrap
1
1
Physical Resistance/Sticking
1
1
Scratched Material
1
1
Burst Container or Vessel
1
1
Shipping Damage or Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Problem with Sterilization
1
1
Material Invagination
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
407
407
No Consequences Or Impact To Patient
41
41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
24
24
Foreign Body In Patient
20
20
No Known Impact Or Consequence To Patient
17
17
No Patient Involvement
16
16
Insufficient Information
15
15
Perforation
14
14
Hemorrhage/Bleeding
9
9
Fever
7
7
Laceration(s)
6
6
Sepsis
5
5
Pain
5
5
Device Embedded In Tissue or Plaque
5
5
Exposure to Body Fluids
5
5
Unspecified Infection
5
5
Septic Shock
3
3
Hematuria
3
3
Swelling/ Edema
2
2
Discomfort
2
2
Low Blood Pressure/ Hypotension
2
2
Anemia
2
2
Urinary Tract Infection
2
2
Extravasation
2
2
Urinary Incontinence
2
2
Nausea
2
2
Pancreatitis
2
2
Abdominal Pain
2
2
Chills
2
2
Injury
1
1
Unspecified Tissue Injury
1
1
Abscess
1
1
Thrombosis/Thrombus
1
1
Fistula
1
1
Tissue Damage
1
1
Lethargy
1
1
Multiple Organ Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific
II
Apr-01-2020
-
-