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TPLC
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Device
catheter, nephrostomy
Product Code
LJE
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
COLOPLAST CORP
SUBSTANTIALLY EQUIVALENT - KIT
2
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
SUBSTANTIALLY EQUIVALENT - KIT
4
YOUCARE TECHNOLOGY CO., LTD. (WUHAN)
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
78
78
2020
50
50
2021
38
38
2022
42
42
2023
132
132
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
62
62
Adverse Event Without Identified Device or Use Problem
59
59
Fluid/Blood Leak
27
27
Break
21
21
Material Rupture
20
20
Difficult to Remove
18
18
Fracture
17
17
Material Separation
15
15
Leak/Splash
13
13
Difficult to Advance
12
12
Material Deformation
12
12
Device Contamination with Chemical or Other Material
10
10
Inflation Problem
10
10
Material Puncture/Hole
10
10
Detachment of Device or Device Component
9
9
Material Split, Cut or Torn
9
9
Use of Device Problem
7
7
Material Fragmentation
7
7
Nonstandard Device
5
5
Material Integrity Problem
5
5
Material Twisted/Bent
5
5
Obstruction of Flow
5
5
Defective Device
4
4
Stretched
4
4
Entrapment of Device
3
3
Crack
3
3
Deflation Problem
3
3
Appropriate Term/Code Not Available
3
3
Device Handling Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Deformation Due to Compressive Stress
2
2
Tear, Rip or Hole in Device Packaging
2
2
Separation Failure
2
2
Difficult to Open or Remove Packaging Material
2
2
Positioning Failure
2
2
Complete Blockage
2
2
Difficult to Insert
2
2
Component Missing
2
2
Unsealed Device Packaging
2
2
Product Quality Problem
2
2
Retraction Problem
1
1
Peeled/Delaminated
1
1
Decrease in Pressure
1
1
Failure to Infuse
1
1
Fitting Problem
1
1
Device Damaged Prior to Use
1
1
Unraveled Material
1
1
Inadequate Instructions for Healthcare Professional
1
1
Mechanical Problem
1
1
Unintended Ejection
1
1
Component Incompatible
1
1
Contamination
1
1
Accessory Incompatible
1
1
Failure to Capture
1
1
Device Dislodged or Dislocated
1
1
Gas/Air Leak
1
1
Compatibility Problem
1
1
Mechanical Jam
1
1
No Flow
1
1
Failure to Advance
1
1
Connection Problem
1
1
Difficult to Open or Close
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device Fell
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
142
142
No Consequences Or Impact To Patient
69
69
No Known Impact Or Consequence To Patient
50
50
No Code Available
18
18
Hemorrhage/Bleeding
15
15
Sepsis
12
12
Obstruction/Occlusion
10
10
Insufficient Information
10
10
Renal Failure
7
7
Urinary Tract Infection
6
6
No Patient Involvement
6
6
Foreign Body In Patient
6
6
Septic Shock
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Perforation
4
4
Hematuria
4
4
Pain
4
4
Device Embedded In Tissue or Plaque
3
3
Pseudoaneurysm
3
3
Hematoma
2
2
Respiratory Failure
2
2
Pneumonia
2
2
Pneumothorax
2
2
Abscess
2
2
Pleural Effusion
2
2
Post Operative Wound Infection
2
2
Failure of Implant
2
2
Hypovolemic Shock
1
1
Perforation of Vessels
1
1
Unspecified Kidney or Urinary Problem
1
1
Anxiety
1
1
Hemothorax
1
1
Bowel Perforation
1
1
Pulmonary Embolism
1
1
Unspecified Tissue Injury
1
1
Internal Organ Perforation
1
1
Urinary Retention
1
1
Abdominal Pain
1
1
Fever
1
1
Cardiac Arrest
1
1
Unspecified Infection
1
1
Purulent Discharge
1
1
Fistula
1
1
Deposits
1
1
Fluid Discharge
1
1
Transient Ischemic Attack
1
1
No Information
1
1
Liver Damage/Dysfunction
1
1
Respiratory Insufficiency
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Inc.
II
Dec-22-2021
2
Cook Inc.
II
Oct-14-2020
3
Cook Inc.
II
Feb-04-2020
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