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TPLC
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show TPLC since
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2024
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Device
dilator, urethral
Product Code
KOE
Regulation Number
876.5520
Device Class
2
Premarket Reviews
Manufacturer
Decision
UROTRONIC INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
9
9
2016
3
3
2017
12
12
2018
23
23
2019
20
20
2020
23
23
2021
19
19
2022
15
15
2023
20
20
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Contamination with Chemical or Other Material
14
14
Burst Container or Vessel
13
13
Leak/Splash
13
13
Material Puncture/Hole
12
12
Inflation Problem
9
9
Break
8
8
Corroded
8
8
Peeled/Delaminated
8
8
Use of Device Problem
7
7
Device Contaminated During Manufacture or Shipping
7
7
Material Deformation
7
7
Material Separation
6
6
Fluid/Blood Leak
5
5
Material Fragmentation
5
5
Contamination /Decontamination Problem
5
5
Adverse Event Without Identified Device or Use Problem
4
4
Flaked
4
4
Packaging Problem
3
3
Pressure Problem
3
3
Material Integrity Problem
3
3
Tear, Rip or Hole in Device Packaging
3
3
Component Missing
2
2
Split
2
2
Device Operates Differently Than Expected
2
2
Material Twisted/Bent
2
2
Output Problem
2
2
Device Handling Problem
2
2
Unsealed Device Packaging
2
2
Unable to Obtain Readings
2
2
Material Frayed
2
2
Gel Leak
1
1
Difficult to Insert
1
1
Fracture
1
1
Balloon rupture
1
1
Crack
1
1
Material Discolored
1
1
Entrapment of Device
1
1
Coiled
1
1
Component(s), broken
1
1
Component Falling
1
1
Contamination
1
1
Difficult to Remove
1
1
Material Rupture
1
1
Product Quality Problem
1
1
Stretched
1
1
Uncoiled
1
1
Other (for use when an appropriate device code cannot be identified)
1
1
Defective Component
1
1
Decrease in Pressure
1
1
Melted
1
1
Misassembled
1
1
Moisture Damage
1
1
Noise, Audible
1
1
Component Misassembled
1
1
Material Split, Cut or Torn
1
1
Physical Resistance/Sticking
1
1
Physical Property Issue
1
1
Therapeutic or Diagnostic Output Failure
1
1
Appropriate Term/Code Not Available
1
1
Detachment of Device or Device Component
1
1
Gas/Air Leak
1
1
Device Operational Issue
1
1
Device Damaged by Another Device
1
1
Difficult to Advance
1
1
Structural Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
59
59
No Consequences Or Impact To Patient
48
48
No Known Impact Or Consequence To Patient
28
28
No Patient Involvement
18
18
Foreign Body In Patient
8
8
No Code Available
7
7
Perforation
4
4
Urinary Tract Infection
2
2
No Information
2
2
Unspecified Mental, Emotional or Behavioural Problem
1
1
Genital Bleeding
1
1
Drug Resistant Bacterial Infection
1
1
Chills
1
1
Swelling
1
1
Other (for use when an appropriate patient code cannot be identified)
1
1
Injury
1
1
Nicks, cuts or tears of dura or other tissues by device
1
1
Abrasion
1
1
Fever
1
1
Unspecified Infection
1
1
Laceration(s)
1
1
Muscle Weakness
1
1
Nausea
1
1
Nerve Damage
1
1
Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Inc.
II
Feb-04-2020
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