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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
Product CodeHEE
Regulation Number 884.5100
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3
2021 1 1
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Leak/Splash 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Foreign Body In Patient 1 1
Emotional Changes 1 1
Pain 1 1

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