BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEILMED SINUGATOR CORDLESS PULSATING NASAL WASH KIT WITH ONE IRRIGATOR, 30 PREMI

    MDR report key: 12142286 · Received July 9, 2021

    Report

    Report Number
    MW5102400
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    May 5, 2021
    Report Date
    July 7, 2021
    Manufacturer
    NEILMED PHARMACEUTICALS, INC.
    Product Code
    KMA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVICE EXPLODED, EYE DAMAGED; ITEM MODEL# SG-ENU-INT, "(B)(4)" I WAS ABLE TO USE THIS 4 TIMES. NOT 4 WEEKS, 4 DAYS, 4 HOURS. PROBABLY ABOUT 4 MINUTES. THAT'S IT, THE ITEM EXPLODED CAUSING INJURY. AFTER FINDING OUT THAT (B)(6) WOULD NOT TAKE A RETURN AND THE SELLER WOULD NOT ALLOW ME TO RETURN IT. THE PROBLEM IS THAT THIS THING IS NOT SEALED PROPERLY. THE TOP CAP PART THAT HOLDS THE NOZZLE HAS NO SEAL AT ALL. THE MOTOR WAS SATURATED. THE CIRCUIT BOARD SWITCHES WERE ACTUALLY CORRODED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039437 NEILMED SINUGATOR CORDLESS PULSATING NASAL WASH KIT WITH ONE IRRIGATOR, 30 PREMI IRRIGATOR, POWERED NASAL KMA NEILMED PHARMACEUTICALS, INC. SG-ENU-INT M050112

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening| O