BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATER PIK WATER FLOSSER

    MDR report key: 10848508 · Received November 16, 2020

    Report

    Report Number
    1712259-2020-00010
    Event Type
    Injury
    Date Received
    November 16, 2020
    Date of Event
    November 5, 2020
    Report Date
    November 16, 2020
    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 · 1

    ON SUNDAY WHILE USING THE MACHINE I FELT THE PIECE OF VENEER COME OFF IN MY MOUTH. I HAVE ATTACHED A PHOTO OF THE CHIP BELOW. THE DENTIST SAID IT CANNOT BE REPAIRED. BEING A VENEER MY INSURANCE PROVIDER WILL NOT COVER REPLACEMENT. THEY PURPOSE A CROWN. MY WORK NORMALLY WOULD COVER 50% FOR CROWNS UP TO A SPECIFIC AMOUNT. I HAVE ATTACHED THE OTHER CROWN FOR REFERENCE ONLY SINCE IT IS ON THE SAME QUOTE. THE MEDAL IS SHOWING AS YOU CAN SEE, SO I THOUGHT I WOULD ASK ABOUT THAT ONE, WHILE I WAS THERE. IT IS ALSO LISTED ON THE ESTIMATE. IT IS APPROXIMATELY (B)(6) DEPENDING ON LAB FEES FOR THE ONE CROWN. THEY CHARGED ME FOR THE EMERGENCY VISIT TODAY WITH XRAYS, AND MY WORK ONLY COVERS UP TO 80%. I PAID (B)(6) OUT OF MY OWN POCKET. I WOULD LIKE TO BE REIMBURSED FOR THE VISIT THIS MORNING AND BE REIMBURSED 50% FOR THE REPLACEMENT CROWN. MY VENEER WAS IN PERFECT CONDITION PRIOR TO USING THE MACHINE. I PURCHASED IT ON THE RECOMMENDATION OF MY DENTAL HYGIENIST." CLAIM PROCEEDINGS WERE DELAYED INITIALLY AS CUSTOMER WAS ON VACATION, AND FURTHERMORE AS THE PRODUCT WAS GIVEN TO A FAMILY MEMBER AFTER THE INCIDENT AND HAD TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308869 WATER PIK WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK INC WP-140 191202CJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other