BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATER PIK SONIC FUSION

    MDR report key: 14053202 · Received April 8, 2022

    Report

    Report Number
    0001712259-2022-00004
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    September 13, 2021
    Report Date
    April 8, 2022
    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 RETURNED PRODUCT TO WP CLAIMING USE OF FLOSSER CAUSED DAMAGE TO CUSTOMER'S BRIDGE. CUSTOMER APPROXIMATES PRODUCT HAD BEEN IN USE FOR 8-9 MONTHS; BRIDGE WAS INSTALLED IN EARLY 1980'S. CUSTOMER DID NOT SUBMIT DOCUMENTATION OF REPAIR OR REQUEST COMPENSATION FOR IT; STATED THEY ONLY WANTED TO VERIFY THE DEVICE PERFORMED TO SPECIFICATION. SF-02 PURCHASE PRICE REFUNDED, ISSUED COURTESY (B)(4). CUSTOMER HAS NOT CONTACTED CS SINCE INITIAL SEPTEMBER CONTACT SO IDENTIFYING APPROPRIATE INFORMATION FOR A FILING WAS EXTREMELY DIFFICULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283651 WATER PIK SONIC FUSION ORAL IRRIGATOR EFS WATER PIK, INC. SF-02 NONE PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other