BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER PIK ONTE-TOUCH POWERPULSE MASSAGE DUAL SHOWER SYSTEM

    MDR report key: 16975319 · Received May 22, 2023

    Report

    Report Number
    0001712259-2023-00006
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    April 17, 2023
    Report Date
    April 25, 2023
    Manufacturer
    WATER PIK INC.
    Product Code
    LYG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    CUSTOMER STATED THAT THEY HAVE OWNED THE SHOWER FOR ABOUT 4 MONTHS. ON (B)(6) 2023, HIS WIFE WAS IN THE SHOWER AND THE FIXED MOUNT PORTION POPPED OFF CAUSING HER TO FALL IN THE TUB. SHE SUSTAINED BRUISING AND IS ACHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816576 WATER PIK ONTE-TOUCH POWERPULSE MASSAGE DUAL SHOWER SYSTEM SHOWER HEAD LYG WATER PIK INC. XPA-133E/763ME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other