BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUATE

    MDR report key: 7174657 · Received January 9, 2018

    Report

    Report Number
    1825660-2017-00221
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    December 12, 2017
    Report Date
    January 9, 2018
    Manufacturer
    RANIR LLC
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE EQ ORBIT BRILLIANT WHITE OPTIMUM SOFT 2 PK ARE FALLING APART WHEN USED. THE RUBBER ELASTOMER PIECES WERE COMING OUT DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18814 EQUATE TOOTHBRUSH, MANUAL EFW RANIR LLC MNTB ORB BRIL WH OPT SO 2PK 287 OR 237

    Patients

    Seq Age Sex Outcome Treatment
    1