BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL BREAST IMPLANT

    MDR report key: 120080 · Received September 5, 1997

    Report

    Report Number
    MW1012092
    Event Type
    Injury
    Date Received
    September 5, 1997
    Date of Event
    October 1, 1996
    Report Date
    September 5, 1997
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER MASTECTOMY IN 1980, HAD ANOTHER MFR'S GEL IMPLANT IN '81. "ENCAPSULATED & MOVED" REPLACED IN '90 (FOR 6 MO) A DOUBLE LUMEN MCGHAN GEL IMPLANT. "I KNOW SILICONE GEL THROUGHOUT MY BODY HAS CAUSED ME TO HAVE TWO HIP REPLACEMENTS IN PAST YEAR." LEFT HIP REPLACEMENT IN 4/97.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Disability