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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
2021 33 33
2022 21 21
2023 26 26
2024 27 27
2025 23 23
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 70 70
Device Damaged by Another Device 39 39
Material Deformation 20 20
Material Separation 8 8
Break 7 7
Material Fragmentation 5 5
Insufficient Information 4 4
Material Integrity Problem 4 4
Detachment of Device or Device Component 4 4
Flaked 4 4
Material Frayed 3 3
No Apparent Adverse Event 3 3
Fracture 3 3
Contamination 2 2
Entrapment of Device 1 1
Peeled/Delaminated 1 1
Device Fell 1 1
Unsealed Device Packaging 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 114 114
Foreign Body In Patient 18 18
Insufficient Information 6 6
No Consequences Or Impact To Patient 4 4
Gastrointestinal Hemorrhage 1 1
Abscess 1 1
Anemia 1 1
Laceration(s) 1 1
Perforation 1 1
Sepsis 1 1

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