BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-SALINE MAMMARY IMPLANT

    MDR report key: 17588 · Received November 11, 1994

    Report

    Report Number
    MW1004003
    Event Type
    Injury
    Date Received
    November 11, 1994
    Date of Event
    September 1, 1994
    Report Date
    November 4, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BREAST INFILTRATING DUCTAL CARCINOMA. ARTHRITIS SYMPTOMS, BREAST CANCER, JOINT PROBLEMS, FROZEN SHOULDER, AND FOOT NEUROMAS. ALSO SEE 1004002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL-SALINE MAMMARY IMPLANT Implant FTR MCGHAN MEDICAL CORP. STYLE 76

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R