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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
2019 6 6
2021 1 1
2022 3 3
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Protrusion/Extrusion 3 3
Output Problem 3 3
Scratched Material 1 1
Deflation Problem 1 1
Display or Visual Feedback Problem 1 1
Inflation Problem 1 1
Increase in Pressure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
High Readings 1 1
Device Displays Incorrect Message 1 1
Deformation Due to Compressive Stress 1 1
Device Dislodged or Dislocated 1 1
Gas/Air Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 2 2
Hemorrhage/Bleeding 2 2
Tissue Damage 1 1
No Consequences Or Impact To Patient 1 1
No Code Available 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LABORIE MEDICAL TECHNOLOGIES, CORP II Jul-25-2019
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