BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NETI POT

    MDR report key: 6278908 · Received January 24, 2017

    Report

    Report Number
    MW5067449
    Event Type
    Injury
    Date Received
    January 24, 2017
    Date of Event
    January 11, 2013
    Report Date
    January 24, 2017
    Manufacturer
    NEILMED PHARMACEUTICALS, INC.
    Product Code
    KCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER USING THE NETI POT FOR SINUS CONGESTION I DEVELOPED A VERY SORE THROAT THAT WOULDN'T GO AWAY. I FINALLY HAD A THROAT CULTURE DONE AND IT SHOWED I HAD AN OVERGROWTH OF YEAST. IT WAS FROM THE CONSTANT IRRIGATION OF MY NOSE/THROAT AND IT RINSED ALL THE "GOOD BACTERIA" AWAY AND PRE-DISPOSED ME TO DEVELOPING A THROAT YEAST INFECTION. DATE OF USE: (B)(6) 2013 - (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: CHRONIC NASAL CONGESTION, SINUSITIS. IS THE PRODUCT OVER-THE-COUNTER: YES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55227 NETI POT APPPLICATOR, ENT KCJ NEILMED PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other