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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Product CodeMEQ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
10 7 6 4 2 4 2 0 0 1 0 0 1 0 0 0

MDR Year MDR Reports MDR Events
2014 22 22
2015 2 2
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Temperature Problem 13 13
Adverse Event Without Identified Device or Use Problem 5 5
Device Displays Incorrect Message 2 2
Power Problem 1 1
Protective Measures Problem 1 1
Insufficient Information 1 1
Fluid/Blood Leak 1 1
Hole In Material 1 1
Leak/Splash 1 1
Overheating of Device 1 1
Failure to Power Up 1 1
Decrease in Pressure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Retention 15 15
Discomfort 15 15
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 2 2
Pain 2 2
No Information 1 1
Blood Loss 1 1
Cardiopulmonary Arrest 1 1
Death 1 1
Fistula 1 1
Incontinence 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jul-28-2009
2 Urologix, Inc. II Jun-30-2011
3 Urologix, Inc. II Mar-19-2010
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