BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER PIK WATER FLOSSER

    MDR report key: 10800795 · Received November 6, 2020

    Report

    Report Number
    1712259-2020-00008
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 9, 2020
    Report Date
    November 6, 2020
    Manufacturer
    WATER PIK INC
    Product Code
    EFS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT IN QUESTION WAS EXAMINED, BUT WE WERE UNABLE TO REACH CUSTOMER TO DETERMINE IF SOMETHING BEYOND A COMPONENT FAILURE OCCURRED.

    Description of Event or Problem · 1

    PER CUSTOMER EMAIL : "I ORDERED ONE OF YOUR ELECTRIC TOOTHBRUSH & WATER FLOSSER COMBO, SF 02 THROUGH (B)(6) ON (B)(6) 2020; (B)(6) RECEIVED IT AND HAVE USED IT SINCE IT ARRIVED WITH NO ISSUES, UNTIL YESTERDAY, WHEN THE UNIT CAUSED AN ELECTRICAL CIRCUIT TO BURN OUT IN MY BATHROOM! THE PLUG ON THE UNIT IS TOAST (MELTED) AND I HAD TO HAVE THE ENTIRE BATHROOM CIRCUIT REPLACED, PLEASE ADVISE ME HOW I CAN RETURN THE WATERPIK FOR A REPLACEMENT." CUSTOMER PROVIDED IMAGES DEMONSTRATING SCORCHED ELECTRICAL OUTLET COVER PLATE AND FUSION PLUG/PRONG. CUSTOMER SERVICE PROVIDED REPLACEMENT AND RETURN LABEL AT TIME OF INTERACTION. CUSTOMER SERVICE CALLED CUSTOMER SEEKING SPECIFIC DETAILS ABOUT EVENTS LEADING UP TO FAILURE; "IS THERE A POSSIBILITY SOMETHING IN THE BATHROOM (HAND TOWEL, CORD FROM ANOTHER ELECTRIC APPLIANCE) MADE CONTACT WITH THE BLADE OF THE PLUG WHILE THE DEVICE WAS BEING PLUGGED IN?"-TYPE QUESTIONS. CS RECEIVED NO RESPONSE FROM CUSTOMER UNTIL OCTOBER IN THE FORM OF THE ARRIVAL OF THE REQUESTED RETURNED PRODUCT. SEVERAL FOLLOW-UP PHONE AND EMAIL REQUESTS ISSUED WITH NO RESPONSE TO DATE, CUSTOMER MAKES NO MENTION OF COMPENSATION FOR DAMAGED PROPERTY IN PRIOR CORRESPONDENCES OR ANY MENTION OF SPECIFIC INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262606 WATER PIK WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK INC SF-02CD010-3

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR