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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device irrigator, powered nasal
Regulation Description Powered nasal irrigator.
Product CodeKMA
Regulation Number 874.5550
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 2 3
2023 4 4
2024 3 3
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 3
Leak/Splash 1 1
Failure to Shut Off 1 1
Moisture Damage 1 1
Patient Device Interaction Problem 1 1
Battery Problem 1 1
Structural Problem 1 1
Failure to Prime 1 1
Explosion 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4 5
No Clinical Signs, Symptoms or Conditions 2 2
Partial Hearing Loss 2 2
Swelling/ Edema 2 2
Tinnitus 2 2
Hearing Impairment 1 1
Sleep Dysfunction 1 1
Hematoma 1 1
Tooth Fracture 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Ear or Labyrinth Problem 1 2
Neck Pain 1 1
Nerve Damage 1 1
Eye Injury 1 1
Fluid Discharge 1 1
Anxiety 1 1
Undesired Nerve Stimulation 1 1
Bacterial Infection 1 2
Inadequate Pain Relief 1 2
Neuralgia 1 1

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