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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
2017 3 3
2018 2 2
2019 6 6
2021 1 1
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Protrusion/Extrusion 3 3
Device Operates Differently Than Expected 2 2
Device Operational Issue 1 1
Device Dislodged or Dislocated 1 1
Output Problem 1 1
Reset Problem 1 1
Scratched Material 1 1
Torn Material 1 1
Deflation Problem 1 1
Display or Visual Feedback Problem 1 1
Fluid Leak 1 1
Hole In Material 1 1
Leak/Splash 1 1
Increase in Pressure 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Defective Component 1 1
High Readings 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Information 3 3
Hemorrhage/Bleeding 2 2
Tissue Damage 1 1
No Consequences Or Impact To Patient 1 1
Abrasion 1 1
No Code Available 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II Aug-10-2018
2 LABORIE MEDICAL TECHNOLOGIES, CORP II Jul-25-2019
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