BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN MEDICAL CORP

    MDR report key: 469559 · Received June 27, 2003

    Report

    Report Number
    MW1028871
    Event Type
    Injury
    Date Received
    June 27, 2003
    Report Date
    June 24, 2003
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1981, BILATERAL AUGMENTATION WITH MCGHAN DOUBLE LUMEN IMPLANTS. IN 2003, PRESENTED WITH APPARENT RUPTURED RIGHT IMPLANT AND BILATERAL CAPSULAR CONTRACTURE IN 2003, PT UNDERWENT BILATERAL CAPSULECTOMIES AND IMPLANT REMOVAL, BILATERAL BREAST BIOPSY AND BILATERAL BREAST AUGMENTATION WITH GEL IMPLANTS MENTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP DOUBLE LUMEN MAMMARY IMPLANT FWM MCGHAN MEDICAL CORP. * AC0422
    2 MCGHAN MEDICAL CORP DOUBLE LUMEN MAMMARY IMPLANT FWM MCGHAN MEDICAL CORP * AC0422

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention