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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
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
63
63
Adverse Event Without Identified Device or Use Problem
59
59
Fluid/Blood Leak
27
27
Break
23
23
Material Rupture
20
20
Difficult to Remove
18
18
Fracture
17
17
Material Separation
15
15
Leak/Splash
13
13
Material Deformation
13
13
Difficult to Advance
12
12
Material Split, Cut or Torn
11
11
Material Puncture/Hole
10
10
Inflation Problem
10
10
Device Contamination with Chemical or Other Material
10
10
Detachment of Device or Device Component
9
9
Material Fragmentation
7
7
Use of Device Problem
7
7
Obstruction of Flow
5
5
Material Twisted/Bent
5
5
Material Integrity Problem
5
5
Nonstandard Device
5
5
Defective Device
4
4
Stretched
4
4
Crack
3
3
Entrapment of Device
3
3
Deflation Problem
3
3
Appropriate Term/Code Not Available
3
3
Component Missing
2
2
Deformation Due to Compressive Stress
2
2
Tear, Rip or Hole in Device Packaging
2
2
Product Quality Problem
2
2
Difficult to Insert
2
2
Difficult to Open or Remove Packaging Material
2
2
Device Handling Problem
2
2
Positioning Failure
2
2
Separation Failure
2
2
Complete Blockage
2
2
Unsealed Device Packaging
2
2
Device Contaminated During Manufacture or Shipping
2
2
Peeled/Delaminated
1
1
Failure to Infuse
1
1
Accessory Incompatible
1
1
Fitting Problem
1
1
Decrease in Pressure
1
1
Mechanical Jam
1
1
Component Incompatible
1
1
Mechanical Problem
1
1
Device Damaged Prior to Use
1
1
Compatibility Problem
1
1
Contamination
1
1
Device Fell
1
1
Failure to Capture
1
1
Failure to Advance
1
1
Gas/Air Leak
1
1
Therapeutic or Diagnostic Output Failure
1
1
Difficult to Open or Close
1
1
Unintended Ejection
1
1
Device Dislodged or Dislocated
1
1
No Flow
1
1
Retraction Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Connection Problem
1
1
Unraveled Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
146
146
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
Hematuria
4
4
Pain
4
4
Perforation
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Device Embedded In Tissue or Plaque
3
3
Pseudoaneurysm
3
3
Post Operative Wound Infection
2
2
Respiratory Failure
2
2
Hematoma
2
2
Pleural Effusion
2
2
Pneumonia
2
2
Pneumothorax
2
2
Failure of Implant
2
2
Abscess
2
2
Cardiac Arrest
1
1
Deposits
1
1
Purulent Discharge
1
1
Fever
1
1
Fistula
1
1
Hemothorax
1
1
Hypovolemic Shock
1
1
Pulmonary Embolism
1
1
Abdominal Pain
1
1
Unspecified Infection
1
1
Liver Damage/Dysfunction
1
1
Internal Organ Perforation
1
1
Perforation of Vessels
1
1
Transient Ischemic Attack
1
1
Urinary Retention
1
1
Anxiety
1
1
Bowel Perforation
1
1
Fluid Discharge
1
1
No Information
1
1
Respiratory Insufficiency
1
1
Unspecified Kidney or Urinary Problem
1
1
Unspecified Tissue Injury
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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