BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATERPIK SINUSENSE

    MDR report key: 2434529 · Received January 24, 2012

    Report

    Report Number
    MW5024047
    Event Type
    Injury
    Date Received
    January 24, 2012
    Date of Event
    October 8, 2011
    Report Date
    October 8, 2011
    Manufacturer
    WATER PIK, INC
    Product Code
    KMA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A WATERPIK SINUSENSE AUTOMATIC (ELECTRIC/BATTERY POWERED) SINUS CLEANER FROM (B)(6) ABOUT A MONTH AGO. I HAVE SERIOUS SINUS ISSUES AND FOR THE FIRST WEEK, THE SINUSENSE WAS HELPING GREATLY. THEN, MY SINUS PROBLEMS STARTED GETTING WORSE THAN THEY WERE BEFORE I STARTED USING THE PRODUCT. COME TO FIND OUT, THE BATTERY COMPARTMENT WAS LEAKING BATTERY ACID INTO THE STERILE SALINE COMPARTMENT. BASICALLY, I WAS FLUSHING MY SINUSES WITH EXTREMELY HARMFUL BATTERY ACID. I AM NOW WORRIED THAT I DID PERMANENT DAMAGE TO MY SINUSES. I FOLLOWED EVERY DIRECTION TO THE T, AND I IN NO WAY MISUSED THIS PRODUCT. I DID A SEARCH FOR THE PRODUCT ONLINE AND ALMOST EVERYONE IS HAVING THE SAME PROBLEM WITH THIS DEVICE. WATERPIK DOESN'T SEEM TO THINK IT'S A BIG DEAL, AND ONLY OFFERS TO REPLACE THE PRODUCT WHEN PEOPLE COMPLAIN. THIS IS SERIOUS. MANY UNSUSPECTING PEOPLE WITH THIS PRODUCT COULD BE FLUSHING THEIR SINUSES WITH BATTERY ACID AS WE SPEAK. YOU CAN READ SOME OF THE REVIEWS FOR THE PRODUCT HERE: (B)(4). RETAILER: (B)(6). THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WATERPIK SINUSENSE SINUS IRRIGATOR KMA WATER PIK, INC SINUSENSE SWI 615

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention