BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATER PIK WATER FLOSSER

    MDR report key: 10171787 · Received June 18, 2020

    Report

    Report Number
    1712259-2020-00005
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    June 4, 2020
    Report Date
    June 18, 2020
    Manufacturer
    WATER PIK, INC.
    Product Code
    EFS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CLAIMS USE OF SONIC FUSION DISLODGED HER CAP AND IS SEEKING REIMBURSEMENT OF REPAIR. CUSTOMER WAS STAYING WITH RELATIVES IN (B)(6) WHEN THIS HAPPENED (RESIDES IN (B)(6)) AND HAD TO GO TO A DENTIST SHE WAS UNFAMILIAR WITH. SHE STATED THAT SHE WAS NOT ABLE TO EAT OR DRINK ANYTHING FOR A WEEK. CUSTOMER SAID THE DENTIST ALMOST WOULD NOT SEE HER BECAUSE HE DID NOT CATEGORIZE THIS AS AN EMERGENCY. CUSTOMER STATES DEFECTIVE CAP HAS SINCE BEEN REPLACED AND CLAIMS THE DENTIST AGREED THAT USE OF THE FLOSSER. CAUSED THE CAP TO DISLODGE. CUSTOMER ADMITS ORAL PROSTHETIC IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636084 WATER PIK WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1