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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implanted electrical device intended for treatment of fecal incontinence
Definition Treatment of chronic fecal incontinence
Product CodeQON
Regulation Number 876.5270
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 22 19 17 23 20 27 27 19 25 42 34 46 31 7

MDR Year MDR Reports MDR Events
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 1 1
Communication or Transmission Problem 1 1
Output Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 1 1
Insufficient Information 1 1

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