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TPLC
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show TPLC since
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Device
dilator, catheter, ureteral
Product Code
EZN
Regulation Number
876.5470
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALLWIN MEDICAL DEVICES, INC
SUBSTANTIALLY EQUIVALENT
1
1. K220781
ARMADA Ureteral Dilator Set, ARMADA Nottingham One
...
COLOPLAST CORP
SUBSTANTIALLY EQUIVALENT - KIT
1
DORNIER MEDTECH AMERICA INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
56
56
2020
40
40
2021
41
41
2022
51
51
2023
85
85
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
51
51
Fluid/Blood Leak
45
45
Adverse Event Without Identified Device or Use Problem
41
41
Inflation Problem
28
28
Material Fragmentation
20
20
Leak/Splash
18
18
Material Puncture/Hole
17
17
Component Misassembled
17
17
Device Handling Problem
15
15
Break
13
13
Material Rupture
11
11
Material Split, Cut or Torn
6
6
Fracture
5
5
Partial Blockage
4
4
Crack
4
4
Difficult to Remove
4
4
Device Slipped
4
4
Failure to Infuse
4
4
Packaging Problem
4
4
Pressure Problem
4
4
Gas/Air Leak
4
4
Device Contaminated During Manufacture or Shipping
4
4
Material Twisted/Bent
4
4
Decrease in Pressure
3
3
Difficult to Advance
3
3
Physical Resistance/Sticking
3
3
Expiration Date Error
3
3
Defective Device
3
3
Component Missing
3
3
Material Separation
3
3
Contamination /Decontamination Problem
2
2
Difficult to Insert
2
2
Material Deformation
2
2
Infusion or Flow Problem
2
2
Difficult to Open or Close
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Dislodged or Dislocated
1
1
Device Contamination with Chemical or Other Material
1
1
Illegible Information
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Inability to Irrigate
1
1
Misassembled
1
1
Delivered as Unsterile Product
1
1
Unsealed Device Packaging
1
1
Deflation Problem
1
1
Disconnection
1
1
Accessory Incompatible
1
1
Detachment of Device or Device Component
1
1
Solder Joint Fracture
1
1
Patient-Device Incompatibility
1
1
Deformation Due to Compressive Stress
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Inadequate or Insufficient Training
1
1
Unraveled Material
1
1
Use of Device Problem
1
1
Fitting Problem
1
1
Device Damaged Prior to Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
138
138
No Consequences Or Impact To Patient
67
67
No Known Impact Or Consequence To Patient
47
47
No Patient Involvement
22
22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Urinary Tract Infection
8
8
Obstruction/Occlusion
7
7
Perforation
6
6
Renal Failure
6
6
Sepsis
5
5
Septic Shock
5
5
Hemorrhage/Bleeding
4
4
Pain
4
4
Insufficient Information
4
4
Respiratory Failure
3
3
Foreign Body In Patient
3
3
Hematuria
3
3
No Code Available
3
3
Pneumothorax
2
2
Tissue Damage
2
2
Pleural Effusion
2
2
Liver Damage/Dysfunction
2
2
Unspecified Tissue Injury
2
2
Swelling/ Edema
1
1
Internal Organ Perforation
1
1
Pneumonia
1
1
Tachycardia
1
1
Hemothorax
1
1
Low Blood Pressure/ Hypotension
1
1
Hypovolemic Shock
1
1
Inflammation
1
1
Pulmonary Embolism
1
1
Abdominal Pain
1
1
Exposure to Body Fluids
1
1
Cardiac Arrest
1
1
Hematoma
1
1
Transient Ischemic Attack
1
1
Urinary Retention
1
1
Confusion/ Disorientation
1
1
Post Operative Wound Infection
1
1
Respiratory Insufficiency
1
1
No Information
1
1
Ascites
1
1
Pseudoaneurysm
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Coloplast Manufacturing US, LLC
II
Apr-02-2024
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