BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATER PIK AQUARIUS WATER FLOSSER

    MDR report key: 10730313 · Received October 23, 2020

    Report

    Report Number
    1712259-2020-00007
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    October 19, 2020
    Report Date
    October 23, 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

    CUSTOMER STATED SHE DOESN'T KNOW IF SHE THINKS THIS WAS BECAUSE OF A PRODUCT DEFECT OR NOT. SAID SHE HAS NOT SEEN THE DENTIST YET BUT HAS CALLED THE OFFICE AND HE WILL BE OUT FOR 2 WEEKS- SAID SHE IS HAVING A HARD TIME EATING AND CAN ONLY EAT WITH THE ONE SIDE OF HER MOUTH- WANTS TO BE COMPENSATED FOR THE DAMAGE" SPOKE WITH CUSTOMER - BRIDGE WAS SEATED (B)(6) 2019 & IS LOCATED IN THE LOWER LEFT BACK OF HER MOUTH. SHE WAS USING THE JT "GENERAL USE" TIP - COULD NOT REMEMBER WHAT PRESSURE SETTING SHE WAS USING - STATED SHE HAD "LOOKED OVER THE MANUAL" BUT COULD NOT REMEMBER IF SHE HAD READ IT. SHE STATED SHE "THINKS" SHE SAW THE DENTIST "LAST MONTH" ((B)(6) 2020). AT THAT TIME NO PROBLEMS WERE DETECTED - SHE HAS NOT BEEN TO THE DENTIST SINCE THE ISSUE OCCURRED AS HE IS "OUT OF THE OFFICE FOR 2 WEEKS" - WHILE USING SHE "FELT SOMETHING LOOSE" AND AFTER SHE PICKED OUT A PIECE OF HER BRIDGE FROM HER MOUTH (SHE STILL HAS THIS PIECE). PRIOR TO USE SHE HAD NOT NOTICED ANYTHING AMISS WITH THE BRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190007 WATER PIK AQUARIUS WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK INC WP-660

    Patients

    Seq Age Sex Outcome Treatment
    1 Other