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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 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Flaked 145 145
Detachment of Device or Device Component 113 113
Adverse Event Without Identified Device or Use Problem 103 103
Break 71 71
Material Fragmentation 48 48
Peeled/Delaminated 38 38
Material Protrusion/Extrusion 27 27
Unraveled Material 23 23
Difficult to Advance 19 19
Improper Chemical Reaction 18 18
Material Twisted/Bent 15 15
Material Integrity Problem 13 13
Difficult to Insert 11 11
Material Deformation 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
Tear, Rip or Hole in Device Packaging 6 6
Device Damaged by Another Device 6 6
Inadequacy of Device Shape and/or Size 6 6
Device Handling Problem 5 5
Missing Information 5 5
Sharp Edges 4 4
Material Too Rigid or Stiff 4 4
Deformation Due to Compressive Stress 4 4
Accessory Incompatible 4 4
Incorrect Measurement 3 3
Unsealed Device Packaging 3 3
Appropriate Term/Code Not Available 3 3
Material Separation 3 3
Component Misassembled 2 2
Device Contaminated During Manufacture or Shipping 2 2
Nonstandard Device 2 2
Patient Device Interaction Problem 2 2
Contamination /Decontamination Problem 2 2
Defective Device 2 2
Fitting Problem 1 1
Biocompatibility 1 1
Positioning Failure 1 1
Failure to Unfold or Unwrap 1 1
Physical Resistance/Sticking 1 1
Scratched Material 1 1
Burst Container or Vessel 1 1
Shipping Damage or Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Problem with Sterilization 1 1
Material Invagination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 407 407
No Consequences Or Impact To Patient 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Foreign Body In Patient 20 20
No Known Impact Or Consequence To Patient 17 17
No Patient Involvement 16 16
Insufficient Information 15 15
Perforation 14 14
Hemorrhage/Bleeding 9 9
Fever 7 7
Laceration(s) 6 6
Sepsis 5 5
Pain 5 5
Device Embedded In Tissue or Plaque 5 5
Exposure to Body Fluids 5 5
Unspecified Infection 5 5
Septic Shock 3 3
Hematuria 3 3
Swelling/ Edema 2 2
Discomfort 2 2
Low Blood Pressure/ Hypotension 2 2
Anemia 2 2
Urinary Tract Infection 2 2
Extravasation 2 2
Urinary Incontinence 2 2
Nausea 2 2
Pancreatitis 2 2
Abdominal Pain 2 2
Chills 2 2
Injury 1 1
Unspecified Tissue Injury 1 1
Abscess 1 1
Thrombosis/Thrombus 1 1
Fistula 1 1
Tissue Damage 1 1
Lethargy 1 1
Multiple Organ Failure 1 1

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