BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGHAN STYLE

    MDR report key: 1913143 · Received November 16, 2010

    Report

    Report Number
    1913143
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    August 31, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ALLERGAN (INAMED AESTHETICS)
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A RIGHT TOTAL GLANDULAR MASTECTOMY AND RECONSTRUCTION, WITH REMOVAL OF THE RIGHT SALINE BREAST IMPLANT AND INSERTION OF RIGHT SILICONE BREAST IMPLANT. DURING THE SAME SURGERY SESSION, THE PATIENT UNDERWENT REMOVAL OF HER DEFLATED LEFT SALINE BREAST IMPLANT, WITH IMPLANT OF A NEW LEFT SILICONE BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN STYLE SALINE BREAST IMPLANT FWM ALLERGAN (INAMED AESTHETICS) MDGHAN STYLE 68 240 CC 68-240

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR