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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)
2021 2022 2023 2024 2025 2026
1 2 1 1 2 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 6 6
2023 2 2
2024 14 14
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Therapeutic or Diagnostic Output Failure 4 4
Premature Activation 4 4
Unexpected Shutdown 2 2
Device Dislodged or Dislocated 2 2
Loss of or Failure to Bond 2 2
Leak/Splash 1 1
Activation Problem 1 1
Material Protrusion/Extrusion 1 1
Unintended System Motion 1 1
Firing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Discomfort 10 10
No Clinical Signs, Symptoms or Conditions 8 8
Emotional Changes 3 3
Pain 3 3
Foreign Body In Patient 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Inadequate Pain Relief 2 2
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Insufficient Information 1 1
Anxiety 1 1

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