BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY FLEX ULTRA +

    MDR report key: 4908023 · Received July 13, 2015

    Report

    Report Number
    1825660-2015-00076
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 12, 2015
    Report Date
    July 12, 2015
    Manufacturer
    RANIR LLC
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DEVICE UNATTENDED

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    TOOTHBRUSH BRISTLES FELL OUT OF TOOTHBRUSH HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454347 EASY FLEX ULTRA + MANUAL TOOTHBRUSH EFW RANIR LLC

    Patients

    Seq Age Sex Outcome Treatment
    1