BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER PIK ULTRA WATER FLOSSER

    MDR report key: 11889893 · Received May 26, 2021

    Report

    Report Number
    1712259-2021-00002
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 19, 2021
    Manufacturer
    WATER PIK INC
    Product Code
    EFS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CLAIM PER INTERACTION NOTES: UNIT SPARKED AND THEN CAUGHT FIRE - SAID IT WAS PLUGGED INTO GFI OUTLET AND IF NOT, COULD HAVE BEEN ELECTROCUTED, SHE SAID - USED CORDLESS UNITS FOR YEARS, AND THIS IS FIRST PLUG-IN UNIT - VERY FAMILIAR WITH THIS PRODUCT - FRIGHTENING EXPERIENCE, LOOKS LIKE CASING NOT PUT TOGETHER CORRECTLY - SENDING PHOTOS- WAITING ON PHOTOS AND I WILL SUBMIT CC FOR HER-ADV SHE WOULD BE CONTACTED W/ 2 BUSINESS DAYS. CUSTOMER SUBMITTED IMAGES DEMONSTRATING CORD FATIGUE AT STRAIN RELIEF. NO INDICATION OF BODILY HARM OR PROPERTY DAMAGE, CONCERN OVER PRODUCT SAFETY SEEM TO BE PRIMARY DRIVERS. RMA ISSUED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787930 WATER PIK ULTRA WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK INC WP-114 181011BJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other