BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE LUMEN MAMMARY IMPLANT

    MDR report key: 16263 · Received September 20, 1994

    Report

    Report Number
    MW1003448
    Event Type
    Injury
    Date Received
    September 20, 1994
    Date of Event
    January 7, 1986
    Report Date
    September 16, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DUE TO ACUTE FIBROCYSTIC DISEASE, ON 1/7/86, RPTR HAD A BILATERAL SUBCUTANEOUS MASTECTOMY WITH SILICONE IMPLANTS. BECAUSE OF THESE IMPLANTS, SHE HAD CONSIDERABLE SCARRING. A CAPSULOTOMY IMPLANT REPLACEMENT WAS RECOMMENDED. (SAME RPTR REFERRED TO IN 1003449 AND 1003450.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE LUMEN MAMMARY IMPLANT Implant BREAST IMPLANT FTR MCGHAN MEDICAL CORP. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| O| R