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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
2021 1 1
2022 2 3
2023 4 4
2024 3 3
2025 3 3
2026 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4 5
Partial Hearing Loss 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Ear infection 2 2
Tinnitus 2 2
Swelling/ Edema 2 2
Ear Pain 1 1
Neck Pain 1 1
Tooth Fracture 1 1
Hematoma 1 1
Unspecified Ear or Labyrinth Problem 1 2
Undesired Nerve Stimulation 1 1
Hearing Impairment 1 1
Obstruction/Occlusion 1 1
Anxiety 1 1
Nerve Damage 1 1
Sleep Dysfunction 1 1
Fluid Discharge 1 1
Eye Injury 1 1
Balance Problems 1 1
Facial Paralysis 1 1
Bacterial Infection 1 2
Neuralgia 1 1
Inadequate Pain Relief 1 2

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