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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, catheter, ureteral
Product CodeEZN
Regulation Number 876.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLWIN MEDICAL DEVICES, INC
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT - KIT 1
DORNIER MEDTECH AMERICA INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 56 56
2020 40 40
2021 41 41
2022 51 51
2023 85 85
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 51 51
Fluid/Blood Leak 45 45
Adverse Event Without Identified Device or Use Problem 41 41
Inflation Problem 28 28
Material Fragmentation 20 20
Leak/Splash 18 18
Material Puncture/Hole 17 17
Component Misassembled 17 17
Device Handling Problem 15 15
Break 13 13
Material Rupture 11 11
Material Split, Cut or Torn 6 6
Fracture 5 5
Partial Blockage 4 4
Crack 4 4
Difficult to Remove 4 4
Device Slipped 4 4
Failure to Infuse 4 4
Packaging Problem 4 4
Pressure Problem 4 4
Gas/Air Leak 4 4
Device Contaminated During Manufacture or Shipping 4 4
Material Twisted/Bent 4 4
Decrease in Pressure 3 3
Difficult to Advance 3 3
Physical Resistance/Sticking 3 3
Expiration Date Error 3 3
Defective Device 3 3
Component Missing 3 3
Material Separation 3 3
Contamination /Decontamination Problem 2 2
Difficult to Insert 2 2
Material Deformation 2 2
Infusion or Flow Problem 2 2
Difficult to Open or Close 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Illegible Information 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Inability to Irrigate 1 1
Misassembled 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Deflation Problem 1 1
Disconnection 1 1
Accessory Incompatible 1 1
Detachment of Device or Device Component 1 1
Solder Joint Fracture 1 1
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Inadequate or Insufficient Training 1 1
Unraveled Material 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 138 138
No Consequences Or Impact To Patient 67 67
No Known Impact Or Consequence To Patient 47 47
No Patient Involvement 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Urinary Tract Infection 8 8
Obstruction/Occlusion 7 7
Perforation 6 6
Renal Failure 6 6
Sepsis 5 5
Septic Shock 5 5
Hemorrhage/Bleeding 4 4
Pain 4 4
Insufficient Information 4 4
Respiratory Failure 3 3
Foreign Body In Patient 3 3
Hematuria 3 3
No Code Available 3 3
Pneumothorax 2 2
Tissue Damage 2 2
Pleural Effusion 2 2
Liver Damage/Dysfunction 2 2
Unspecified Tissue Injury 2 2
Swelling/ Edema 1 1
Internal Organ Perforation 1 1
Pneumonia 1 1
Tachycardia 1 1
Hemothorax 1 1
Low Blood Pressure/ Hypotension 1 1
Hypovolemic Shock 1 1
Inflammation 1 1
Pulmonary Embolism 1 1
Abdominal Pain 1 1
Exposure to Body Fluids 1 1
Cardiac Arrest 1 1
Hematoma 1 1
Transient Ischemic Attack 1 1
Urinary Retention 1 1
Confusion/ Disorientation 1 1
Post Operative Wound Infection 1 1
Respiratory Insufficiency 1 1
No Information 1 1
Ascites 1 1
Pseudoaneurysm 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Coloplast Manufacturing US, LLC II Apr-02-2024
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