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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dilator, urethral
Regulation Description Urethral dilator.
Product CodeKOE
Regulation Number 876.5520
Device Class 2


Premarket Reviews
ManufacturerDecision
UROTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 23 23
2021 19 19
2022 15 15
2023 20 20
2024 22 22
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 12 12
Inflation Problem 9 9
Leak/Splash 9 9
Burst Container or Vessel 9 9
Corroded 8 8
Material Fragmentation 8 8
Device Contaminated During Manufacture or Shipping 8 8
Device Contamination with Chemical or Other Material 6 6
Material Deformation 6 6
Contamination /Decontamination Problem 4 4
Fluid/Blood Leak 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Break 3 3
Packaging Problem 3 3
Unable to Obtain Readings 2 2
Disconnection 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Twisted/Bent 2 2
Output Problem 2 2
Device Handling Problem 2 2
Material Split, Cut or Torn 2 2
Melted 1 1
Moisture Damage 1 1
Unsealed Device Packaging 1 1
Decrease in Pressure 1 1
Difficult to Remove 1 1
Contamination 1 1
Fracture 1 1
Gel Leak 1 1
Material Separation 1 1
Use of Device Problem 1 1
Component Missing 1 1
Material Integrity Problem 1 1
Pressure Problem 1 1
Noise, Audible 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 75 75
No Consequences Or Impact To Patient 12 12
No Patient Involvement 9 9
No Known Impact Or Consequence To Patient 9 9
Foreign Body In Patient 2 2
Pain 2 2
Fever 1 1
Hemorrhage/Bleeding 1 1
Incontinence 1 1
Unspecified Infection 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Genital Bleeding 1 1
Discomfort 1 1
Muscle Weakness 1 1
Nausea 1 1
Internal Organ Perforation 1 1
Perforation 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Chills 1 1
Drug Resistant Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Feb-04-2020
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