BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATER PIK SONIC FUSION

    MDR report key: 13054286 · Received December 21, 2021

    Report

    Report Number
    0001712259-2021-00010
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    December 10, 2021
    Report Date
    December 21, 2021
    Manufacturer
    WATER PIK, INC.
    Product Code
    EFS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER STATED HIS FLOSSER HAD RUN WELL FOR THE LAST FEW WEEKS, HE HAD ONLY PURCHASED IT 3 WEEKS AGO, END OF NOVEMBER. STATED HE DID NOT USE ADDITIVES OR DROP IT. THE HOSE CONNECTION PART FAILED AND WHILE BRUSHING, THE TOOTHBRUSH FELL. (B)(6) STATED THAT WHEN THIS HAPPENED HE SAW ELECTRICAL PARTS AND CLAIMS TO HAVE RECEIVED AN ELECTRICAL SHOCK. CUSTOMER IMAGES DEMONSTRATE DATE CODE ON UNDERSIDE OF FLOSSER AS "21032X" (TRAILING CHARACTERS ARE NOT IN-FRAME). ADDITIONAL DETAILS THAT LED TO ADVERSE EVENT HAVE BEEN REQUESTED. THUS FAR CUSTOMER HAS BEEN UNCOOPERATIVE/UNWILLING TO DISCUSS IN DETAIL. CUSTOMER STATED THEY ONLY WANTED THE DEVICE TO BE REPLACED. PRODUCT RETURN HAS BEEN REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948347 WATER PIK SONIC FUSION ORAL IRRIGATOR EFS WATER PIK, INC. SF-04 21032XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other