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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stylet for catheter, gastro-urology
Product CodeEZB
Regulation Number 876.5130
Device Class 1

MDR Year MDR Reports MDR Events
2017 58 58
2018 46 46
2019 65 65
2020 65 65
2021 69 69
2022 103 103
2023 179 179
2024 86 86

Device Problems MDRs with this Device Problem Events in those MDRs
Flaked 139 139
Break 123 123
Detachment of Device or Device Component 116 116
Adverse Event Without Identified Device or Use Problem 102 102
Material Integrity Problem 58 58
Device Damaged by Another Device 58 58
Material Fragmentation 46 46
Peeled/Delaminated 38 38
Material Deformation 30 30
Material Protrusion/Extrusion 29 29
Unraveled Material 27 27
Difficult to Advance 20 20
Material Twisted/Bent 19 19
Improper Chemical Reaction 16 16
Entrapment of Device 13 13
Difficult to Insert 11 11
Difficult to Remove 8 8
Use of Device Problem 8 8
Material Too Rigid or Stiff 7 7
Bent 6 6
Material Separation 6 6
Tear, Rip or Hole in Device Packaging 6 6
Device Contamination with Chemical or Other Material 6 6
Inadequacy of Device Shape and/or Size 6 6
Device Handling Problem 5 5
Missing Information 5 5
Device-Device Incompatibility 5 5
Sharp Edges 4 4
Deformation Due to Compressive Stress 4 4
Device Damaged Prior to Use 4 4
Product Quality Problem 3 3
Incorrect Measurement 3 3
Appropriate Term/Code Not Available 3 3
Unsealed Device Packaging 3 3
Defective Device 3 3
Accessory Incompatible 3 3
Component Missing 3 3
Component Misassembled 2 2
Fracture 2 2
Off-Label Use 2 2
Activation, Positioning or Separation Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Contamination /Decontamination Problem 2 2
Patient Device Interaction Problem 2 2
Out-Of-Box Failure 1 1
Problem with Sterilization 1 1
Structural Problem 1 1
Device Operates Differently Than Expected 1 1
Metal Shedding Debris 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 362 362
No Consequences Or Impact To Patient 126 126
No Known Impact Or Consequence To Patient 65 65
Foreign Body In Patient 27 27
No Patient Involvement 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Device Embedded In Tissue or Plaque 19 19
Perforation 15 15
Insufficient Information 14 14
No Information 11 11
Hemorrhage/Bleeding 10 10
Fever 7 7
Laceration(s) 6 6
Sepsis 5 5
Death 5 5
Pain 5 5
Hematuria 4 4
No Code Available 4 4
Unspecified Infection 4 4
Exposure to Body Fluids 3 3
Septic Shock 3 3
Urinary Incontinence 2 2
Inflammation 2 2
Anemia 2 2
Chills 2 2
Nausea 2 2
Extravasation 2 2
Swelling/ Edema 2 2
Low Blood Pressure/ Hypotension 2 2
Urinary Tract Infection 2 2
Abdominal Pain 2 2
Disability 1 1
Edema 1 1
Blood Loss 1 1
Multiple Organ Failure 1 1
Cardiac Arrest 1 1
Dysuria 1 1
Injury 1 1
Thrombosis/Thrombus 1 1
Swelling 1 1
Dyspnea 1 1
Abscess 1 1
Unspecified Tissue Injury 1 1
Hypoxia 1 1
Tissue Damage 1 1
Internal Organ Perforation 1 1
Fistula 1 1
Lethargy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific II Apr-01-2020
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