BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC HIGH TEC TRIPLE WALL LOW BLEED BREAST IMPLANT

    MDR report key: 13375 · Received May 19, 1994

    Report

    Report Number
    MW1002094
    Event Type
    Injury
    Date Received
    May 19, 1994
    Date of Event
    November 10, 1967
    Report Date
    March 2, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD A MASTECTOMY ON 5/7/85, SHE HAD ANOTHER CO'S IMPLANT ON 11/10/67 AND THIS CO'S IMPLANTS ON 9/17/86. SHE HAS HAD ADHESIONS, INFLAAMMATION OF VAGINA AND BOWEL, UNEXPLAINED BLEEDING OF VAGINA AND BOWEL, ULCERATIVE COLITIS, BASAL CELL CARCINOMAS (9) AND BREAST CANCER. THESE EVENTUALLY LEAD TO HYSTERECTOMY, COLECTOMY WITH ILIOAANAL PULLTHROUGH, MASTECTOMY AND BREAST RECONSTRUCTION. (SAME RPTR REFERRED TO IN 1001176.) (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC HIGH TEC TRIPLE WALL LOW BLEED BREAST IMPLANT Implant FTR MCGHAN MEDICAL CORP. STYLE 40

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| L| R RIGHT BREAST RECONSTRUCTION| RIGHT BREAST IMPLANT| LEFT BREAST IMPLANT