BEUDAMED
    FDA Adverse Event Other Summary report: N

    MC GHAN

    MDR report key: 1061878 · Received June 3, 2008

    Report

    Report Number
    MW5007348
    Event Type
    Other
    Date Received
    June 3, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 2, 2008
    Manufacturer
    MC GHAN
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RUPTURE (LEAK?) OF SILICONE GEL IMPLANT LEFT BREAST. SIXTEEN YEARS AFTER ORIGINAL PLACEMENT. PATIENT UNDERWENT CAPSULECTOMY BECAUSE OF INCREASE CAPSULAR CONTRACTURE IN 2008. TWO MONTHS LATER PRESENTED WITH LEFT BREAST INFECTION AND EXPOSURE OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MC GHAN SILICONE BREAST IMPLANT FTR MC GHAN

    Patients

    Seq Age Sex Outcome Treatment
    1