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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
Product CodeKMA
Regulation Number 874.5550
Device Class 1


Premarket Reviews
ManufacturerDecision
RHINOSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2017 1 1
2018 1 1
2020 1 1
2021 1 1
2022 2 2
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Corroded 1 1
Moisture Damage 1 1
Failure to Prime 1 1
Structural Problem 1 1
Battery Problem 1 1
Device Operates Differently Than Expected 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4 4
Eye Injury 2 2
Hearing Impairment 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Infiltration into Tissue 1 1
Bacterial Infection 1 1
Cerebrospinal Fluid Leakage 1 1
Spinal Column Injury 1 1
Tinnitus 1 1
Anxiety 1 1
Inadequate Pain Relief 1 1
Respiratory Tract Infection 1 1
Tooth Fracture 1 1
Sleep Dysfunction 1 1
Fluid Discharge 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Neuralgia 1 1
Partial Hearing Loss 1 1
Unspecified Ear or Labyrinth Problem 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Water Pik, Inc. II May-25-2012
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