BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATER PIK WATER FLOSSER

    MDR report key: 10848144 · Received November 16, 2020

    Report

    Report Number
    1712259-2020-00009
    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

    HIS CROWN FELL OUT - ONLY A YEAR OLD - HE WANTS COMPENSATION FOR DENTAL WORK - HE HAS NOT BEEN TO DENTIST YET. HE DOES NOT WANT A REFUND OR NEW UNIT - WANTS COMPENSATION FOR DAMAGES. NO PRIOR ISSUES WITH ORAL HEALTH. PRESSURE 4-5 PSI, JET TIP USED WAS THE PS100, DISCUSSED PROPER USE, THE SAFETY OF PRODUCT, AND ORAL HEALTH OF CUSTOMER. HE ASKED MULTIPLE TIMES WHEN HE WOULD HEAR BACK FROM US AND WHEN HE COULD SEE A RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308605 WATER PIK WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK INC WP-861

    Patients

    Seq Age Sex Outcome Treatment
    1 Other