BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATER PIK ULTRA/NANO COMBO FLOSSER

    MDR report key: 16600125 · Received March 23, 2023

    Report

    Report Number
    0001712259-2023-00002
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    January 6, 2023
    Report Date
    March 23, 2023
    Manufacturer
    WATER PIK INC.
    Product Code
    EFS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    CUSTOMER CONTACTED CUSTOMER SERVICE INDICATING USE OF FLOSSER CAUSED TOOTH TO BREAK. LAPSE IN COMPLAINT ENTRY DUE TO PERSONNEL ASSIGNED TO CLAIM EXITING THE ORGANIZATION. CUSTOMER SERVICE ATTEMPTED FOLLOW-UP CONTACT WITH CUSTOMER (B)(6) 2023, AWAITING RETURN CORRESPONDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739270 WATER PIK ULTRA/NANO COMBO FLOSSER ORAL IRRIGATOR EFS WATER PIK INC. WP-140/310 220606BJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other