BEUDAMED
    FDA Adverse Event Other Summary report: N

    MCGHAN

    MDR report key: 470223 · Received July 2, 2003

    Report

    Report Number
    470223
    Event Type
    Other
    Date Received
    July 2, 2003
    Date of Event
    February 7, 2003
    Report Date
    February 10, 2003
    Manufacturer
    INAMED
    Product Code
    FTR
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT PUT IN FOR BREAST RECONSTRUCTION. BECAME INFECTED AND REMOVED 2 DAYS LATER. ENTIRE BREAST AREA WAS RED AND INFLAMED. YELLOW FLUID WAS PRESENT. IMPLANT WAS REMOVED AND SENT TO PATH.-GROSS ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN SILICONE BREAST IMPLANT FTR INAMED NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other