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Device
catheter, urological
Regulation Description
Urological catheter and accessories.
Product Code
KOD
Regulation Number
876.5130
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALLWIN MEDICAL DEVICES, INC
SUBSTANTIALLY EQUIVALENT
1
UROGEN PHARMA LTD
SUBSTANTIALLY EQUIVALENT
1
WELL LEAD MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
1370
1370
2021
1387
1387
2022
1280
1280
2023
1162
1162
2024
1262
1262
2025
691
691
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
857
857
Improper Chemical Reaction
462
462
Adverse Event Without Identified Device or Use Problem
440
440
Difficult to Remove
436
436
Material Twisted/Bent
353
353
Device Misassembled During Manufacturing /Shipping
346
346
Material Rupture
338
338
Component Misassembled
324
324
Material Puncture/Hole
273
273
Decrease in Pressure
255
255
Deflation Problem
253
253
Sharp Edges
226
226
Incorrect Measurement
202
202
Fluid/Blood Leak
200
200
Difficult to Insert
189
189
Tear, Rip or Hole in Device Packaging
157
157
Partial Blockage
156
156
Short Fill
154
154
Nonstandard Device
136
136
Component Missing
128
128
Biocompatibility
121
121
Contamination /Decontamination Problem
111
111
Material Fragmentation
106
106
Inaccurate Flow Rate
104
104
Failure to Infuse
95
95
Material Split, Cut or Torn
94
94
Leak/Splash
75
75
Unsealed Device Packaging
72
72
Patient Device Interaction Problem
72
72
Material Too Rigid or Stiff
68
68
Device Handling Problem
65
65
Break
62
62
Product Quality Problem
60
60
Material Protrusion/Extrusion
55
55
Difficult to Open or Remove Packaging Material
52
52
Inflation Problem
47
47
Device Contamination with Chemical or Other Material
46
46
Unintended Deflation
43
43
Inability to Irrigate
42
42
Device Slipped
42
42
Inadequacy of Device Shape and/or Size
38
38
Deformation Due to Compressive Stress
35
35
Defective Device
35
35
Device Fell
34
34
Device Contaminated During Manufacture or Shipping
34
34
Incomplete or Missing Packaging
34
34
Material Separation
32
32
Failure to Deflate
31
31
Naturally Worn
29
29
Material Deformation
26
26
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4542
4542
No Consequences Or Impact To Patient
807
807
No Known Impact Or Consequence To Patient
469
469
Pain
460
460
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
451
451
Urinary Tract Infection
442
442
Discomfort
186
186
No Patient Involvement
181
181
Hemorrhage/Bleeding
101
101
Patient Problem/Medical Problem
93
93
Hematuria
87
87
Insufficient Information
68
68
Foreign Body In Patient
66
66
Blood Loss
63
63
Unspecified Tissue Injury
62
62
Unspecified Infection
55
55
Bacterial Infection
52
52
No Code Available
49
49
Urinary Retention
37
37
Sepsis
29
29
Abdominal Distention
28
28
Skin Inflammation/ Irritation
28
28
Tissue Breakdown
25
25
Swelling/ Edema
16
16
Perforation
16
16
Abrasion
15
15
Abdominal Pain
15
15
Exposure to Body Fluids
13
13
Bruise/Contusion
13
13
Irritability
12
12
Fever
11
11
Fistula
11
11
Incontinence
11
11
Irritation
11
11
Skin Discoloration
10
10
Burning Sensation
10
10
Obstruction/Occlusion
10
10
Inflammation
10
10
Laceration(s)
10
10
Dysuria
9
9
Micturition Urgency
8
8
Injury
8
8
Genital Bleeding
8
8
Cramp(s) /Muscle Spasm(s)
8
8
Urinary Incontinence
7
7
Hematoma
7
7
Septic Shock
7
7
Cancer
7
7
Low Blood Pressure/ Hypotension
6
6
Unspecified Gastrointestinal Problem
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
C.R. Bard Inc
II
Feb-24-2022
2
C.R. Bard, Inc.
II
Apr-16-2021
3
Cardinal Health 200, LLC
I
Feb-16-2024
4
Covidien Llc
II
May-14-2020
5
TELEFLEX LLC
II
Nov-11-2022
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