BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER PIK CORDLESS WATER FLOSSER

    MDR report key: 12927858 · Received December 3, 2021

    Report

    Report Number
    0001712259-2021-00008
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 3, 2021
    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

    THERMAL EVENT DAMAGING OUTLET AND WALL. CUSTOMER CLAIMS DEVICE WAS CHARGING IN "OFF" POSITION FOR APPROXIMATELY 30 MINUTES. CUSTOMER RETURNED HOME TO AROMA OF "ADHESIVE" AND BURNING, FOUND CHARGER BRICK CHARRED WALL/OUTLET IT WAS PLUGGED INTO; NO INJURY SUSTAINED. CUSTOMER CLAIMS ELECTRICIAN ANALYSIS IDENTIFIED EVENT NOT CAUSED BY OUTLET OR WIRING. LED NIGHTLIGHT WAS ALSO PLUGGED INTO OUTLET. COMPLAINT DELIVERED VIA CERTIFIED MAIL TO WPI. RETURN TRACKING - (B)(4). CUSTOMER WAS UPGRADED TO WP-672.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819834 WATER PIK CORDLESS WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK, INC. WP-360 210217SEU

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other