BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UP&UP ESBTWN INTRDNTL SO PICK

    MDR report key: 8883550 · Received August 12, 2019

    Report

    Report Number
    1825660-2019-00592
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    June 18, 2019
    Report Date
    August 12, 2019
    Manufacturer
    RANIR LLC
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED HE/SHE TRIED THE PRODUCT FOR THE FIRST TIME. CONSUMER STATED THE RETAILER NEEDED TO "WORK ON THE BREAKAGE ISSUE AS THESE DO NOT HOLD UP". NO CONTACT INFORMATION PROVIDED, UNABLE TO RETRIEVE THE PRODUCT. BASED ON THE CONSUMER'S COMMENTS, IT APPEARS THE BRUSH BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678288 UP&UP ESBTWN INTRDNTL SO PICK TOOTHBRUSH, MANUAL EFW RANIR LLC ESBTWN INTRDNTL SO PICK W/TRVL 100CT

    Patients

    Seq Age Sex Outcome Treatment
    1