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TPLC
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Device
dilator, urethral
Regulation Description
Urethral dilator.
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
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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