BEUDAMED
    FDA Adverse Event Summary report: N

    TEXTURED IMPLANT, 200 CC

    MDR report key: 14044 · Received June 15, 1994

    Report

    Report Number
    MW1002491
    Date Received
    June 15, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD THIS BREAST IMPLANT IMPLANTED TO REPLACE THE TISSUE EXPANDER ON 5/7/90. IN 8/90, SHE DEVELOPED A RASH AROUND HER BELT LINE. BY 12/13/90, RPTR HAD DEVELOPED CAPSULAR CONTRACTURE ON THE RIGHT. ON 3/18/91, SHE HAD REVISION OF BREAST RECONSTRUCTION AND EXCHANGE OF IMPLANT. (*) (SAME RPTR REFERRED TO IN 1002490 AND 1002492.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEXTURED IMPLANT, 200 CC Implant FTR MCGHAN MEDICAL CORP. STYLE 100

    Patients

    Seq Age Sex Outcome Treatment
    1 *