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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
Regulation Description Urological catheter and accessories.
Product CodeEZB
Regulation Number 876.5130
Device Class 1

MDR Year MDR Reports MDR Events
2020 65 65
2021 69 69
2022 103 103
2023 179 179
2024 133 133
2025 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Flaked 148 148
Detachment of Device or Device Component 118 118
Adverse Event Without Identified Device or Use Problem 111 111
Break 73 73
Material Fragmentation 50 50
Peeled/Delaminated 40 40
Material Protrusion/Extrusion 28 28
Unraveled Material 23 23
Difficult to Advance 20 20
Improper Chemical Reaction 19 19
Material Twisted/Bent 15 15
Material Integrity Problem 13 13
Material Deformation 12 12
Difficult to Insert 11 11
Entrapment of Device 10 10
Device-Device Incompatibility 9 9
Device Contamination with Chemical or Other Material 8 8
Use of Device Problem 7 7
Difficult to Remove 7 7
Accessory Incompatible 6 6
Tear, Rip or Hole in Device Packaging 6 6
Deformation Due to Compressive Stress 6 6
Inadequacy of Device Shape and/or Size 6 6
Device Damaged by Another Device 6 6
Missing Information 5 5
Material Too Rigid or Stiff 5 5
Device Handling Problem 5 5
Sharp Edges 4 4
Defective Device 3 3
Unsealed Device Packaging 3 3
Appropriate Term/Code Not Available 3 3
Nonstandard Device 3 3
Incorrect Measurement 3 3
Material Separation 3 3
Component Misassembled 2 2
Contamination /Decontamination Problem 2 2
Patient Device Interaction Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Failure to Advance 1 1
Failure to Unfold or Unwrap 1 1
Biocompatibility 1 1
Problem with Sterilization 1 1
Component Missing 1 1
Positioning Failure 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Shipping Damage or Problem 1 1
Scratched Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Fell 1 1
Material Invagination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 422 422
No Consequences Or Impact To Patient 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Foreign Body In Patient 21 21
No Known Impact Or Consequence To Patient 17 17
No Patient Involvement 16 16
Insufficient Information 15 15
Perforation 14 14
Fever 10 10
Hemorrhage/Bleeding 9 9
Exposure to Body Fluids 7 7
Hematuria 6 6
Laceration(s) 6 6
Unspecified Infection 5 5
Sepsis 5 5
Pain 5 5
Device Embedded In Tissue or Plaque 5 5
Unspecified Tissue Injury 4 4
Septic Shock 3 3
Abdominal Pain 2 2
Pancreatitis 2 2
Nausea 2 2
Urinary Incontinence 2 2
Anemia 2 2
Chills 2 2
Discomfort 2 2
Extravasation 2 2
Swelling/ Edema 2 2
Low Blood Pressure/ Hypotension 2 2
Urinary Tract Infection 2 2
Multiple Organ Failure 1 1
Injury 1 1
Thrombosis/Thrombus 1 1
Abscess 1 1
Tissue Damage 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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