BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL MARKER

    MDR report key: 2021684 · Received March 13, 2011

    Report

    Report Number
    MW5019791
    Event Type
    Malfunction
    Date Received
    March 13, 2011
    Date of Event
    August 1, 2010
    Report Date
    March 13, 2011
    Product Code
    MIJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY DOCTOR INSERTED A MARKER IN MY BREAST AFTER A STEREOTACTIC BREAST BIOPSY. I HAVE HAD INTENSE ITCHING AND PAIN AT THE SITE AND I THINK THE MARKER HAS MOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METAL MARKER MIJ

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other