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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, upper urinary tract
Product CodeEYC
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 6 6
2021 6 6
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 12 12
Fluid/Blood Leak 12 12
Complete Blockage 11 11
Obstruction of Flow 11 11
Expulsion 10 10
Burst Container or Vessel 6 6
Infusion or Flow Problem 6 6
Material Integrity Problem 5 5
Material Rupture 4 4
Suction Problem 4 4
Decrease in Suction 2 2
Display or Visual Feedback Problem 2 2
Leak/Splash 1 1
Compatibility Problem 1 1
Break 1 1
Mechanical Problem 1 1
Crack 1 1
Material Puncture/Hole 1 1
Device Fell 1 1
Failure to Sense 1 1
Gas/Air Leak 1 1
Decreased Sensitivity 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Retention 22 22
No Clinical Signs, Symptoms or Conditions 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Unspecified Kidney or Urinary Problem 4 4
No Known Impact Or Consequence To Patient 3 3
Urinary Incontinence 2 2
Abdominal Pain 1 1
No Consequences Or Impact To Patient 1 1

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