BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATERPIK COMPLETE CARE

    MDR report key: 7179261 · Received January 10, 2018

    Report

    Report Number
    0001712259-2017-00005
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    December 18, 2017
    Report Date
    February 2, 2018
    Manufacturer
    WATER PIK, INC.
    Product Code
    EFS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EXPERIENCED ELECTRICAL FAILURE AND INTERNAL ARCING/BURNING, ALL DAMAGE WAS CONTAINED INSIDE THE UNIT. FAILURE ANALYSIS SHOWED THAT THE MOV COMPONENT FAILED AND CAUSED THE ELECTRICAL FAILURE. MOV'S ARE DESIGNED TO PROTECT THE CIRCUITRY BUT CAN EITHER BE OVERWHELMED OR WORN OUT AND RESULT IN THE TYPE OF FAILURE SEEN.

    Description of Event or Problem · 0

    PER THE CUSTOMER....CLAIMS THE DEVICE WAS PLUGGED IN BUT NOT IN USE WHEN UNIT BEGAN TO PRODUCE A BURNING SMELL. THE CUSTOMER CLAIMS THE PRODUCT PRODUCED A BLACK FILM RESIDUE ON THE COUNTERTOP AND MELTED THEIR WALL OUTLET. CUSTOMER IS SEEKING A REPLACEMENT PRODUCT OR REFUND.

    Additional Manufacturer Narrative · 1

    UNIT IN QUESTION HAS NOT BEEN RETURNED FOR TESTING AND EVALUATION.

    Description of Event or Problem · 1

    PER THE CUSTOMER....CLAIMS THE DEVICE WAS PLUGGED IN BUT NOT IN USE WHEN UNIT BEGAN TO PRODUCE A BURNING SMELL. THE CUSTOMER CLAIMS THE PRODUCT PRODUCED A BLACK FILM RESIDUE ON THE COUNTERTOP AND MELTED THEIR WALL OUTLET. CUSTOMER IS SEEKING A REPLACEMENT PRODUCT OR REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24769 WATERPIK COMPLETE CARE ORAL IRRIGATION UNIT EFS WATER PIK, INC. WP-871

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other