BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER PIK NANOL WATER FLOSSER

    MDR report key: 17515148 · Received August 11, 2023

    Report

    Report Number
    0001712259-2023-00013
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 31, 2023
    Report Date
    August 11, 2023
    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

    CUSTOMER STATED WAS USING UNIT ON MID-PRESSURE AND BACK CAP PIECE OF TB-100 TIP CAME OFF RESULTING IN BEING SWALLOWED. CLAIMS THAT THROAT IS NOW GETTING SORE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564616 WATER PIK NANOL WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK INC. WP-310 190518AJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other