BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOMEYES

    MDR report key: 12046954 · Received June 22, 2021

    Report

    Report Number
    3002808441-2021-00003
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Report Date
    June 22, 2021
    Manufacturer
    BEAVER VISITEC INTERNATIONAL LIMITED
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE ARE LOTS OF WHITE PLASTIC BITS WITHIN THE CHAMBER OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943730 CUSTOMEYES KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD BEAVER VISITEC INTERNATIONAL LIMITED 590307 3270402

    Patients

    Seq Age Sex Outcome Treatment
    1