BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATER PIK CORDLESS SELECT WATER FLOSSER

    MDR report key: 11784093 · Received May 6, 2021

    Report

    Report Number
    1712259-2021-00001
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 6, 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

    CUST STATED THAT THE UNIT HAS CAUSED HER CROWN TO FALL OUT. STATED THAT THE CROWN WAS IN GOOD REPAIR AND NOT OLD. INITIAL CONTACT OCCURRED (B)(6) 2021; CUSTOMER INDICATED THEY WOULD PROVIDE DOCUMENTATION FROM DENTAL PROFESSIONAL THAT SUBSTANTIATES THEIR CLAIM. UNIT WAS RECEIVED BEFORE CUSTOMER COULD PROVIDE DOCUMENTATION. HAS REACHED OUT TO DENTIST BUT HAS NOT PROVIDED ANY PAPERWORK OR INFO ON WHAT THE DENTIST HAS SAID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682753 WATER PIK CORDLESS SELECT WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK INC WF-10W010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other