BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN MEDICAL CORP.

    MDR report key: 526049 · Received April 26, 2004

    Report

    Report Number
    MW1031981
    Event Type
    Injury
    Date Received
    April 26, 2004
    Report Date
    April 23, 2004
    Manufacturer
    MCGHAN MEDICAL CORP. INAMED
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT AUGMENTED WITH SALINE BREAST IMPLANTS IN 1995. NO PROBLEMS UNTIL 2004 WHEN THEY NOTED A SIGNIFICANT DECREASE SIZE ON RIGHT SIDE. PT UNDERWENT BILATERIAL IMPLANT REMOVAL AND REPLACEMENT WITH SILICONE GEL IMPLANTS. RIGHT IMPLANT PARTIALLY DEFLATED AND LEFT IMPLANT INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP. SALINE FILLED MAMMARY IMPLANT FWM MCGHAN MEDICAL CORP. INAMED LT. STYLE 468 GK1421
    2 MCGHAN MEDICAL CORP SALINE FILLED MAMMARY IMPLANT FWM MCGHAN MEDICAL CORP, INAMED RT. STYLE 468 GK1376

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention