BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATERPIK WATER FLOSSER

    MDR report key: 5101391 · Received September 24, 2015

    Report

    Report Number
    0001712259-2015-00006
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    September 23, 2015
    Report Date
    November 19, 2015
    Manufacturer
    WATER PIK, INC.
    Product Code
    EFS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT IN QUESTION HAS NOT YET BEEN RETURNED FOR TESTING AND EVALUATION.

    Additional Manufacturer Narrative · 1

    RETURNED UNIT TESTED AND FOUND TO BE WITHIN THE NORMAL OPERATING PRESSURE RANGE AND WAS OPERATING AS DESIGNED. THERE IS NO KNOWN SITUATION WHERE PRESSURE CAN TEMPORARILY INCREASE. MOST LIKELY SITUATION IS THAT CUSTOMER AIMED WATER JET AT SOFT TISSUE INSTEAD OF GUM AREA AND CAUSED PAIN. THIS IS WARNED AGAINST IN THE PRODUCT INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    PER THE CUSTOMER....FATHER CLAIMS THE (B)(6) DAUGHTER INJURED THE ROOF OF HER MOUTH WHILE FLOSSING. SAYS DAUGHTER HAS USED HER WP-360 FOR SOME TIME WITH THE HIGH PRESSURE TIP AND HAS HAD NO PROBLEMS. SUDDENLY THE PRESSURE BECAME MUCH HIGHER THAN USUAL AND CAUSED SMALL ABRASIONS ON THE ROOF OF HER MOUTH. DAUGHTER HAS BRACES, DID NOT RECEIVE MEDICAL ATTENTION AND ABRASIONS HEALED QUICKLY. CUSTOMER REQUESTED A REPLACEMENT UNIT.

    Description of Event or Problem · 1

    PER THE CUSTOMER....FATHER CLAIMS THE (B)(6) YEAR OLD DAUGHTER INJURED THE ROOF OF HER MOUTH WHILE FLOSSING. SAYS DAUGHTER HAS USED HER WP-360 FOR SOME TIME WITH THE HIGH PRESSURE TIP AND HAS HAD NO PROBLEMS. SUDDENLY THE PRESSURE BECAME MUCH HIGHER THAN USUAL AND CAUSED SMALL ABRASIONS ON THE ROOF OF HER MOUTH. DAUGHTER HAS BRACES, DID NOT RECEIVE MEDICAL ATTENTION AND ABRASIONS HEALED QUICKLY. CUSTOMER REQUESTED A REPLACEMENT UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631981 WATERPIK WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK, INC. WP-360 KL120316GA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other