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TPLC
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show TPLC since
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Device
tray, catheterization, sterile urethral, with or without catheter (kit)
Product Code
FCM
Regulation Number
876.5130
Device Class
2
Premarket Reviews
Manufacturer
Decision
COLOPLAST
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
6
6
2015
5
5
2016
14
14
2017
33
33
2018
61
61
2019
79
79
2020
86
86
2021
85
85
2022
59
59
2023
48
48
2024
32
32
Device Problems
MDRs with this Device Problem
Events in those MDRs
Component Missing
71
71
Product Quality Problem
48
48
Improper Chemical Reaction
45
45
Difficult to Insert
39
39
Component Misassembled
31
31
Fluid/Blood Leak
23
23
Adverse Event Without Identified Device or Use Problem
23
23
Material Twisted/Bent
21
21
Patient-Device Incompatibility
21
21
Biocompatibility
18
18
Inaccurate Flow Rate
18
18
Incorrect Measurement
17
17
Nonstandard Device
17
17
Material Integrity Problem
15
15
Unintended Deflation
15
15
Leak/Splash
13
13
Deflation Problem
12
12
Defective Device
12
12
No Flow
10
10
Misassembled
10
10
Material Deformation
10
10
Gel Leak
9
9
Device Operates Differently Than Expected
9
9
Deformation Due to Compressive Stress
8
8
Partial Blockage
8
8
Material Fragmentation
7
7
Material Rupture
7
7
Sharp Edges
6
6
Detachment of Device or Device Component
6
6
Contamination /Decontamination Problem
5
5
Break
5
5
Bent
5
5
Insufficient Information
4
4
Appropriate Term/Code Not Available
4
4
Structural Problem
4
4
Inadequacy of Device Shape and/or Size
4
4
Difficult to Remove
3
3
Premature Separation
3
3
Shipping Damage or Problem
3
3
Obstruction of Flow
3
3
Failure to Deflate
3
3
Material Split, Cut or Torn
3
3
Tear, Rip or Hole in Device Packaging
3
3
Disconnection
3
3
Inadequate Lubrication
3
3
Burst Container or Vessel
3
3
Moisture or Humidity Problem
3
3
Defective Component
3
3
Therapeutic or Diagnostic Output Failure
3
3
Kinked
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
200
200
No Known Impact Or Consequence To Patient
142
142
No Consequences Or Impact To Patient
122
122
Urinary Tract Infection
53
53
No Patient Involvement
45
45
Pain
17
17
Hemorrhage/Bleeding
15
15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
14
14
Patient Problem/Medical Problem
11
11
No Information
9
9
Discomfort
8
8
Insufficient Information
8
8
Unspecified Infection
6
6
Blood Loss
6
6
Foreign Body In Patient
6
6
No Code Available
5
5
Tissue Damage
4
4
Injury
3
3
Sepsis
2
2
Hematuria
2
2
Abrasion
2
2
Irritation
2
2
Urinary Retention
2
2
Skin Tears
2
2
Tissue Breakdown
2
2
Hypersensitivity/Allergic reaction
1
1
Urinary Incontinence
1
1
Nausea
1
1
Failure of Implant
1
1
Skin Inflammation/ Irritation
1
1
Staphylococcus Aureus
1
1
Burning Sensation
1
1
Burn(s)
1
1
Exposure to Body Fluids
1
1
Reaction
1
1
Pressure Sores
1
1
Irritability
1
1
Distress
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health
II
Dec-02-2022
2
Cardinal Health 200, LLC
I
Feb-16-2024
3
Customed, Inc
II
Mar-21-2012
4
Go Medical Industries Pty., Ltd.
II
Oct-21-2011
5
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-06-2024
6
MEDLINE INDUSTRIES, LP - Northfield
II
Aug-03-2023
7
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
8
Nurse Assist, Inc
II
May-25-2011
9
Teleflex Medical
III
Aug-06-2014
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