BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTURA MLB

    MDR report key: 1820548 · Received August 23, 2010

    Report

    Report Number
    2032230-2010-00003
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    September 4, 2009
    Report Date
    July 6, 2010
    Manufacturer
    SENORX, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K081079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE IS UNK. THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE INVESTIGATION FOR THIS EVENT IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PT RECEIVED PARTIAL BREAST BRACHYTHERAPY USING THE CONTURA MLB DEVICE, PT PRESENTED WITH A SYMPTOMATIC SEROMA LEADING TO SKIN AND FAT NECROSIS SEVEN MONTHS LATER. PT UNDERWENT ADJACENT TISSUE TRANSFER AND REARRANGEMENT WITH RHOMBOID FLAP FIVE MONTHS LATER, ONE YEAR AFTER THE COMPLETION OF THE BRACHYTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTURA MLB JAQ SENORX, INC. B012-45

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention PARTIAL BREAST BRACHYTHERAPY| (DATE OF TX (B)(6))