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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
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 3
DORNIER MEDTECH AMERICA INC
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 28 28
2015 30 30
2016 19 19
2017 65 65
2018 58 58
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 91 91
Fluid/Blood Leak 54 54
Inflation Problem 50 50
Adverse Event Without Identified Device or Use Problem 46 46
Break 35 35
Material Rupture 31 31
Leak/Splash 29 29
Kinked 23 23
Material Fragmentation 21 21
Material Puncture/Hole 20 20
Component Misassembled 17 17
Deflation Problem 16 16
Device Handling Problem 15 15
Bent 10 10
Difficult to Remove 9 9
Device Packaging Compromised 7 7
Device Contamination with Chemical or Other Material 7 7
Material Split, Cut or Torn 6 6
Pressure Problem 6 6
Material Separation 6 6
Fracture 5 5
Device Operates Differently Than Expected 5 5
Material Deformation 5 5
Difficult to Advance 5 5
Gas/Air Leak 4 4
Failure to Infuse 4 4
Device Contaminated During Manufacture or Shipping 4 4
Physical Resistance/Sticking 4 4
Packaging Problem 4 4
Partial Blockage 4 4
Detachment Of Device Component 4 4
Crack 4 4
Device Slipped 4 4
Device Damaged Prior to Use 4 4
Decrease in Pressure 4 4
Material Twisted/Bent 4 4
Misassembled 3 3
Component Missing 3 3
Hole In Material 3 3
Positioning Problem 3 3
Expiration Date Error 3 3
Defective Device 3 3
Detachment of Device or Device Component 3 3
Infusion or Flow Problem 2 2
Difficult to Open or Close 2 2
Deformation Due to Compressive Stress 2 2
Contamination /Decontamination Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Torn Material 2 2
Difficult to Insert 2 2
Balloon rupture 2 2
Use of Device Problem 2 2
Unsealed Device Packaging 2 2
Peeled/Delaminated 1 1
Difficult To Position 1 1
Delivered as Unsterile Product 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Solder Joint Fracture 1 1
Stretched 1 1
Inadequate or Insufficient Training 1 1
Unraveled Material 1 1
Balloon burst 1 1
Accessory Incompatible 1 1
Inability to Irrigate 1 1
Disconnection 1 1
Display or Visual Feedback Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Noise, Audible 1 1
Illegible Information 1 1
Split 1 1
Patient-Device Incompatibility 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 152 152
No Clinical Signs, Symptoms or Conditions 138 138
No Known Impact Or Consequence To Patient 123 123
No Patient Involvement 47 47
No Information 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Urinary Tract Infection 9 9
Perforation 9 9
Pain 8 8
No Code Available 8 8
Obstruction/Occlusion 7 7
Renal Failure 6 6
Hemorrhage/Bleeding 6 6
Extravasation 5 5
Sepsis 5 5
Septic Shock 5 5
Rupture 5 5
Hematuria 4 4
Tissue Damage 4 4
Internal Organ Perforation 4 4
Foreign Body In Patient 4 4
Injury 4 4
Insufficient Information 4 4
Respiratory Failure 3 3
Liver Damage/Dysfunction 2 2
Pneumothorax 2 2
Pleural Effusion 2 2
Unspecified Tissue Injury 2 2
Swelling/ Edema 1 1
Respiratory Insufficiency 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Pneumonia 1 1
Hematoma 1 1
Hemothorax 1 1
Low Blood Pressure/ Hypotension 1 1
Hypovolemic Shock 1 1
Unspecified Infection 1 1
Inflammation 1 1
Pulmonary Embolism 1 1
Abdominal Pain 1 1
Exposure to Body Fluids 1 1
Cardiac Arrest 1 1
Death 1 1
Burn, Thermal 1 1
Confusion/ Disorientation 1 1
Ascites 1 1
Pseudoaneurysm 1 1
Peritonitis 1 1
Post Operative Wound Infection 1 1
Transient Ischemic Attack 1 1
Urinary Retention 1 1
Vomiting 1 1
Tachycardia 1 1
Thrombus 1 1

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