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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, urethral
Product CodeKOE
Regulation Number 876.5520
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Leak/Splash 13 13
Burst Container or Vessel 13 13
Material Puncture/Hole 12 12
Inflation Problem 9 9
Corroded 8 8
Peeled/Delaminated 8 8
Break 8 8
Material Deformation 7 7
Device Contaminated During Manufacture or Shipping 7 7
Use of Device Problem 7 7
Material Separation 6 6
Material Fragmentation 5 5
Fluid/Blood Leak 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
Material Twisted/Bent 2 2
Device Operates Differently Than Expected 2 2
Material Frayed 2 2
Component Missing 2 2
Device Handling Problem 2 2
Unsealed Device Packaging 2 2
Split 2 2
Output Problem 2 2
Unable to Obtain Readings 2 2
Difficult to Insert 1 1
Moisture Damage 1 1
Entrapment of Device 1 1
Component Falling 1 1
Difficult to Advance 1 1
Material Rupture 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Gel Leak 1 1
Detachment of Device or Device Component 1 1
Crack 1 1
Component(s), broken 1 1
Noise, Audible 1 1
Stretched 1 1
Device Damaged by Another Device 1 1
Decrease in Pressure 1 1
Physical Resistance/Sticking 1 1
Melted 1 1
Physical Property Issue 1 1
Appropriate Term/Code Not Available 1 1
Material Split, Cut or Torn 1 1
Therapeutic or Diagnostic Output Failure 1 1
Structural Problem 1 1
Balloon rupture 1 1
Component Misassembled 1 1
Misassembled 1 1
Coiled 1 1
Uncoiled 1 1
Difficult to Remove 1 1
Gas/Air Leak 1 1
Device Operational Issue 1 1
Fracture 1 1
Product Quality Problem 1 1
Contamination 1 1
Defective Component 1 1
Material Discolored 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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