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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, anesthesia, paracervical
Regulation Description Obstetric anesthesia set.
Product CodeHEE
Regulation Number 884.5100
Device Class 2

MDR Year MDR Reports MDR Events
2016 1 1
2017 4 4
2018 1 1
2019 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Needle 3 3
Break 2 2
Leak/Splash 2 2
Component Missing 2 2
Detachment of Device or Device Component 2 2
Material Integrity Problem 1 1
Unintended Movement 1 1
Misassembled 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 2 2
Pain 1 1
Emotional Changes 1 1
Insufficient Information 1 1

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