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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, double lumen female urethrographic
Product CodeFGH
Regulation Number 876.5130
Device Class 2

MDR Year MDR Reports MDR Events
2015 19 19
2016 3 3
2020 1 1
2021 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Deflation Problem 6 6
Burst Container or Vessel 5 5
Leak/Splash 4 4
Torn Material 2 2
Unintended Movement 1 1
Failure to Deliver 1 1
Split 1 1
Material Protrusion/Extrusion 1 1
Pressure Problem 1 1
Inflation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 16 16
No Information 6 6
No Clinical Signs, Symptoms or Conditions 3 3

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