BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATER PIK CORDLESS PLUS WATER FLOSSER

    MDR report key: 11890250 · Received May 26, 2021

    Report

    Report Number
    1712259-2021-00003
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 26, 2021
    Manufacturer
    WATER PIK, INC.
    Product Code
    EFS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CONTACTED (B)(6) CUSTOMER SERVICE (PHL) CLAIMING USE OF WP-450 CAUSED DENTAL BRIDGE TO DISLODGE AND A BLISTER UNDER THE USER'S TONGUE. CUSTOMER REJECTS STATEMENT THAT FLOSSERS ARE NOT KNOW TO DAMAGE PROPERLY INSTALLED AND SOUND ORAL PROSTHETICS CITING THEIR DENTIST'S CLAIM "IT SHOULD NOT HAVE HAPPENED." CUSTOMER APPROXIMATES BRIDGE IS 13 MONTHS OLD, AND INDICATED DENTAL COST AS "(B)(6)." CUSTOMER HAS NOT PROVIDED DOCUMENTATION OF SERVICE, COLLABORATING WITH PHL TO REFUND PURCHASE COST AND RETURN TO FTC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786868 WATER PIK CORDLESS PLUS WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK, INC. 200410

    Patients

    Seq Age Sex Outcome Treatment
    1 Other