BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER PIK CORDLESS ADVANCED WATER FLOSSER

    MDR report key: 17627183 · Received August 25, 2023

    Report

    Report Number
    0001712259-2023-00014
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    August 10, 2023
    Report Date
    August 25, 2023
    Manufacturer
    WATER PIK INC.
    Product Code
    EFS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    CUSTOMER CHATTED IN ON 8/10 REGARDING INCIDENT THAT TOOK PLACE A MONTH PRIOR. CUSTOMER ALLEGES THAT THE UNIT "EXPLODED" DURING USE. SAYS A PIECE BROKE OFF AND HIT HIS LIP. NO DAMAGE TO PERSON OR PROPERTY (OTHER THAN THE FLOSSER). DID NOT SEEK MEDICAL OR PROFESSIONAL ATTENTION. SEEKING EITHER REPLACEMENT OR REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932208 WATER PIK CORDLESS ADVANCED WATER FLOSSER ORAL IRRIGATOR EFS WATER PIK INC. WP-563 170227HAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other