BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PWTB 1G W/2 TRI SWP HDS

    MDR report key: 7898250 · Received September 21, 2018

    Report

    Report Number
    1825660-2018-00417
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    September 6, 2018
    Report Date
    September 21, 2018
    Manufacturer
    RANIR LLC
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BRUSH HEAD HAS SNAPPED OFF RESULTING IN THE BROKEN PART BEING STUCK ON THE BRUSH HANDLE. THE WHITE PIECE BROKE WHERE THE WHITE BRUSH HEAD ATTACHED WHILE HER HUSBAND WAS BRUSHING HIS TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740616 LIFE PWTB 1G W/2 TRI SWP HDS TOOTHBRUSH, POWERED JEQ RANIR LLC PWTB 1G W/2 TRI SWP HDS

    Patients

    Seq Age Sex Outcome Treatment
    1