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TPLC
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Device
catheter, nephrostomy
Product Code
LJE
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORP.
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
COLOPLAST CORP
SUBSTANTIALLY EQUIVALENT - KIT
2
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT - KIT
4
SUBSTANTIALLY EQUIVALENT
4
GYRUS ACMI, INC.
SUBSTANTIALLY EQUIVALENT
1
JBW7 INNOVATIONS, LLC
SUBSTANTIALLY EQUIVALENT
1
YOUCARE TECHNOLOGY CO., LTD. (WUHAN)
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
9
9
2016
26
26
2017
60
60
2018
69
69
2019
78
78
2020
50
50
2021
38
38
2022
42
42
2023
132
132
2024
27
27
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
81
81
Adverse Event Without Identified Device or Use Problem
64
64
Material Rupture
59
59
Fluid/Blood Leak
45
45
Break
38
38
Leak/Splash
34
34
Difficult to Remove
25
25
Material Separation
21
21
Fracture
20
20
Device Contamination with Chemical or Other Material
17
17
Detachment of Device or Device Component
16
16
Material Deformation
14
14
Inflation Problem
13
13
Difficult to Advance
13
13
Material Split, Cut or Torn
12
12
Material Puncture/Hole
11
11
Material Fragmentation
9
9
Appropriate Term/Code Not Available
9
9
Use of Device Problem
7
7
Torn Material
7
7
Obstruction of Flow
6
6
Material Integrity Problem
6
6
Material Twisted/Bent
5
5
Nonstandard Device
5
5
Device Operates Differently Than Expected
5
5
Fitting Problem
5
5
Device Dislodged or Dislocated
4
4
Deflation Problem
4
4
Detachment Of Device Component
4
4
Connection Problem
4
4
Defective Device
4
4
Stretched
4
4
Difficult to Insert
4
4
Device Contaminated During Manufacture or Shipping
3
3
Crack
3
3
Entrapment of Device
3
3
Physical Resistance/Sticking
2
2
Difficult to Open or Remove Packaging Material
2
2
Kinked
2
2
Separation Failure
2
2
Complete Blockage
2
2
Device Handling Problem
2
2
Unsealed Device Packaging
2
2
Mechanical Jam
2
2
Deformation Due to Compressive Stress
2
2
Positioning Failure
2
2
Component Missing
2
2
Device Packaging Compromised
2
2
Hole In Material
2
2
Tear, Rip or Hole in Device Packaging
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
160
160
No Consequences Or Impact To Patient
137
137
No Known Impact Or Consequence To Patient
85
85
No Code Available
58
58
Hemorrhage/Bleeding
21
21
Foreign Body In Patient
14
14
Sepsis
13
13
No Patient Involvement
12
12
Insufficient Information
11
11
No Information
10
10
Obstruction/Occlusion
10
10
Renal Failure
8
8
Urinary Tract Infection
6
6
Perforation
6
6
Tissue Damage
6
6
Septic Shock
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Device Embedded In Tissue or Plaque
4
4
Hematuria
4
4
Pain
4
4
Unspecified Infection
3
3
Blood Loss
3
3
Pseudoaneurysm
3
3
Abscess
3
3
Fistula
2
2
Pneumothorax
2
2
Failure of Implant
2
2
Hematoma
2
2
Respiratory Failure
2
2
Internal Organ Perforation
2
2
Post Operative Wound Infection
2
2
Fever
2
2
Pleural Effusion
2
2
Pneumonia
2
2
Pulmonary Embolism
1
1
Hemothorax
1
1
Respiratory Insufficiency
1
1
Embolism
1
1
Unspecified Tissue Injury
1
1
Anxiety
1
1
Perforation of Vessels
1
1
Fluid Discharge
1
1
Unspecified Kidney or Urinary Problem
1
1
Urinary Retention
1
1
Deposits
1
1
Cardiac Arrest
1
1
Transient Ischemic Attack
1
1
Purulent Discharge
1
1
Bowel Perforation
1
1
Urinary Incontinence
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Jul-09-2013
2
C.R. Bard, Inc.
II
Nov-04-2016
3
Cook Inc.
II
Dec-22-2021
4
Cook Inc.
II
Oct-14-2020
5
Cook Inc.
II
Feb-04-2020
6
Cook Inc.
II
Mar-24-2016
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