BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER PIK SIDEKICK FLOSSER

    MDR report key: 12005048 · Received June 15, 2021

    Report

    Report Number
    1712259-2021-00004
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 15, 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 · 1

    CUSTOMER CLAIMS UNIT WAS PLUGGED IN APPROXIMATELY AN HOUR AFTER USE. CUSTOMER HEARD A POP SOUND AND ENTERED THE BATHROOM TO FIND UNIT TRANSFORMER ON FIRE. NO INJURIES OR SIGNIFICANT PROPERTY DAMAGED SUSTAINED SAVE FOR PLATE COVER AND POSSIBLY OUTLET. CUSTOMER HAS NOT SOUGHT REPAIR ESTIMATES AND EXPRESSED DISINTEREST IN DOING SO. CUSTOMER DID NOT OBSERVE ANY DAMAGE TO TRANSFORMER PRIOR TO OCCURRENCE AND COULD NOT ISOLATE ANY OTHER OUTLYING CAUSES SUCH AS CHEMICAL ATTACK. REPLACED AND REQUESTED RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902263 WATER PIK SIDEKICK FLOSSER ORAL IRRIGATOR EFS WATER PIK INC WF-04CD012-3 180607AP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other