BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER PIK ION WATER FLOSSER

    MDR report key: 19506933 · Received June 10, 2024

    Report

    Report Number
    0001712259-2024-00010
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    May 10, 2024
    Report Date
    June 10, 2024
    Manufacturer
    WATER PIK INC.
    Product Code
    EFS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    OWNED ABOUT 8-10 MONTHS -- USED 3X OR MORE DAILY -- CHARGE BRICK 5V 2.4A -- NO ADDITIVES -- NO CLEANING -- DID NOT STORE WATER BETWEEN USES -- CONNECTION TO CHARGER STARTED TO SMOKE -- CONNECTIONS BURNED ON CABLE AND MACHINE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859345 WATER PIK ION WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK INC. WF-12 221126HAP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other