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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stylet, ureteral
Regulation Description Urological catheter and accessories.
Product CodeEYA
Regulation Number 876.5130
Device Class 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 33 33
2022 21 21
2023 26 26
2024 27 27
2025 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 57 57
Device Damaged by Another Device 44 44
Material Deformation 13 13
Break 8 8
Material Separation 8 8
Insufficient Information 5 5
Material Fragmentation 5 5
Material Integrity Problem 4 4
Detachment of Device or Device Component 4 4
Flaked 4 4
Material Frayed 3 3
Device Fell 3 3
Fracture 3 3
No Apparent Adverse Event 2 2
Entrapment of Device 1 1
Peeled/Delaminated 1 1
Unsealed Device Packaging 1 1
Contamination 1 1
Shipping Damage or Problem 1 1
Material Twisted/Bent 1 1
Device Handling Problem 1 1
Material Protrusion/Extrusion 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 102 102
Foreign Body In Patient 18 18
No Consequences Or Impact To Patient 7 7
Insufficient Information 5 5
Device Embedded In Tissue or Plaque 3 3
Sepsis 1 1
Gastrointestinal Hemorrhage 1 1
Perforation 1 1
Anemia 1 1
Laceration(s) 1 1
Abscess 1 1

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