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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tympanostomy tube delivery product with drug
Definition Intended to place a tympanostomy tube across the tympanic membrane under local anesthesia.
Product CodeQJA
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 0 0 0 0 0 0 1 2 1 2 1 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 6 6
2023 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Therapeutic or Diagnostic Output Failure 1 1
Firing Problem 1 1
Unexpected Shutdown 1 1
Activation Problem 1 1
Leak/Splash 1 1
Unintended System Motion 1 1
Premature Activation 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Discomfort 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Inadequate Pain Relief 2 2
Foreign Body In Patient 1 1
Insufficient Information 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Anxiety 1 1

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