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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, cystometric, hydraulic
Product CodeFEN
Regulation Number 876.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
SRS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 3 3
2023 3 3
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 2 2
High Readings 1 1
Scratched Material 1 1
Gas/Air Leak 1 1
Inflation Problem 1 1
Material Protrusion/Extrusion 1 1
Increase in Pressure 1 1
Device Dislodged or Dislocated 1 1
Display or Visual Feedback Problem 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 2 2
Hemorrhage/Bleeding 2 2
Abrasion 1 1
Discomfort 1 1
Anxiety 1 1

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