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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
Regulation Description Urodynamics measurement system.
Product CodeFEN
Regulation Number 876.1620
Device Class 2

MDR Year MDR Reports MDR Events
2016 10 10
2017 3 3
2018 2 2
2019 6 6
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 4 4
Device Operates Differently Than Expected 3 3
Material Protrusion/Extrusion 2 2
Disconnection 2 2
Defective Component 2 2
High Readings 1 1
Connection Problem 1 1
Reset Problem 1 1
Leak/Splash 1 1
Increase in Pressure 1 1
Sticking 1 1
No Flow 1 1
Output Problem 1 1
Torn Material 1 1
Device Operational Issue 1 1
Break 1 1
Fluid Leak 1 1
Hole In Material 1 1
No Device Output 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Defective Device 1 1
Deformation Due to Compressive Stress 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
No Information 3 3
Urinary Retention 2 2
No Code Available 1 1
Pain 1 1
Tissue Damage 1 1
Insufficient Information 1 1
High Blood Pressure/ Hypertension 1 1
No Consequences Or Impact To Patient 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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