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TPLC
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Device
irrigator, powered nasal
Product Code
KMA
Regulation Number
874.5550
Device Class
1
Premarket Reviews
Manufacturer
Decision
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
3
3
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
Material Integrity Problem
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
Device Operates Differently Than Expected
1
1
Corroded
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
4
4
Partial Hearing Loss
2
2
Eye Injury
2
2
Swelling/ Edema
2
2
Tinnitus
2
2
Hearing Impairment
1
1
Sleep Dysfunction
1
1
No Information
1
1
Hematoma
1
1
Tooth Fracture
1
1
Spinal Column Injury
1
1
No Known Impact Or Consequence To Patient
1
1
Unspecified Ear or Labyrinth Problem
1
1
Neck Pain
1
1
Respiratory Tract Infection
1
1
Nerve Damage
1
1
Fluid Discharge
1
1
Anxiety
1
1
Undesired Nerve Stimulation
1
1
Cerebrospinal Fluid Leakage
1
1
Hemorrhage/Bleeding
1
1
Infiltration into Tissue
1
1
Bacterial Infection
1
1
Inadequate Pain Relief
1
1
Neuralgia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Water Pik, Inc.
II
May-25-2012
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