BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMOSITE EVALUATION DEVICE

    MDR report key: 1333059 · Received March 2, 2009

    Report

    Report Number
    MW5010138
    Event Type
    Injury
    Date Received
    March 2, 2009
    Date of Event
    February 25, 2009
    Report Date
    March 2, 2009
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A MAMMOSITE CAVITY EVALUATION DEVICE INSERTED IN 2009 UNEVENTFULLY. SHE HAD TO BE RETURNED TO OR THE SAME DAY, DUE TO LEFT BREAST EXPLORATION, SECONDARY TO BLEEDING, AND MALFUNCTIONING OF THE MAMMOSITE CAVITY EVALUATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOSITE EVALUATION DEVICE JAQ 08L05MA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization