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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transurethral occlusion insert, urinary incontinence-control, female
Definition Transurethral insert for urinary occlusion/control in women with urinary incontinence
Product CodeOCK
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2015 1 1
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Migration or Expulsion of Device 2 2
Difficult to Remove 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Tract Infection 1 1
Discomfort 1 1
Hematuria 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Rochester Medical Corp II Jun-25-2010
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