BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER PIK EVOLUTION WATER FLOSSER

    MDR report key: 13028195 · Received December 17, 2021

    Report

    Report Number
    0001712259-2021-00009
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    November 22, 2021
    Report Date
    December 17, 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

    CUSTOMER STATED THAT HIS WF-07 CAUSED AN ELECTRICAL FIRE IN HIS BATHROOM AND DAMAGE TO THE OUTLET. HE STATED THAT THE BREAKER POPPED AND THAT THEY WERE HOME DURING THIS EXPERIENCE. AFTER ATTEMPTING TO REACH THE CUSTOMER MULTIPLE TIMES VIA PHONE, WE WERE ABLE TO CONTACT HIM WITH QUESTIONS ABOUT USE, STORAGE, CLEANING/ADDITIVES, DAMAGE CAUSED, IF HE REACHED OUT TO INSURANCE OR ELECTRICIAN, AND RECEIPT. WE RECEIVED A RESPONSE WITH PHOTOS OF OUTLET AND FLOSSER CLAIMING UNIT WAS USED DAILY WITH TWO USERS AND ONLY PLUGGED IN WHILE IN USE. CUSTOMER STATED THAT BASE AND CORD SEEMED REALLY HOT AND THAT HE HAS NOT YET CALLED TO HAVE OUTLET REPLACED. AT THIS TIME, A REFUND FOR THE UNIT HAS BEEN ISSUED AND A REPLACEMENT WF-09 HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921820 WATER PIK EVOLUTION WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK, INC. WF-07 210323AJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other