BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATER PIK WATER FLOSSER

    MDR report key: 10080466 · Received May 21, 2020

    Report

    Report Number
    0001712259-2020-00002
    Event Type
    Injury
    Date Received
    May 21, 2020
    Date of Event
    April 22, 2020
    Report Date
    May 21, 2020
    Manufacturer
    WATER PIK, INC.
    Product Code
    EFS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    COMPLAINT ORIGINATED VIA (B)(6) COMMENT. CUSTOMER CLAIMS TO BE NEW USER OF FLOSSER PRODUCTS. CUSTOMER STATED IN PHONE CALL: FRONT-OF-TOOTH FILLING DISLODGED DURING FIRST USE ATTEMPT AT LOW PRESSURE (USING JT-360). THE CUSTOMER CLAIMS THE FILLING WAS INSTALLED IN (B)(6) 2019. CUSTOMER ACCEPTS EXPLANATION "THIS HAPPENING HAS NOT BEEN FOUND TO OCCUR WITH FLOSSER PRODUCTS WHEN USED ON OTHERWISE HEALTHY TEETH/FILLINGS" AND DOESN'T BELIEVE THE DEVICE IS DEFECTIVE, BUT FEELS THIS WOULD NOT HAVE HAPPENED IF SHE WERE NOT USING THE PRODUCT. CUSTOMER STATED WATERPIK SHOULD "DO THE RIGHT THING AND PAY FOR FILLING REPLACEMENT." REFUND AND PRODUCT RETURN REQUESTED. CUSTOMER REFUSED UPGRADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541397 WATER PIK WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK, INC. WP360

    Patients

    Seq Age Sex Outcome Treatment
    1