BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATERPIK WATER FLOSSER

    MDR report key: 6002891 · Received October 6, 2016

    Report

    Report Number
    0001712259-2016-00004
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 5, 2016
    Manufacturer
    WATER PIK, INC.
    Product Code
    EFS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PER THE CUSTOMER....CLAIMS TO HAVE SUSTAINED INJURY AT THE TIME OF INITIAL USE, UNIT WAS SET TO MAXIMUM PRESSURE SETTING TO PRIME AS PER PRODUCT LITERATURE. CUSTOMER DID NOT LESSEN PRESSURE WHEN ATTEMPTING TO USE THE PRODUCT AND CLAIMS TO HAVE EXPERIENCED BLEEDING GUMS. CUSTOMER CLAIMS BACTERIAL PNEUMONIA/INFECTION WERE SUSTAINED DUE TO USE OF THE PRODUCT. CUSTOMER ACKNOWLEDGES THAT THE PRODUCT WAS NOT USED AS INSTRUCTED. CUSTOMER EMAILED HER DENTIST, THE DENTIST WROTE BACK AND TOLD HER THAT SHE PROBABLY DID NOT USE THE DEVICE CORRECTLY AND DID NOT AGREE WITH HER SELF-DIAGNOSIS ABOUT THE BACTERIAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654923 WATERPIK WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK, INC. WP-140

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other