BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN MEDICAL CORP

    MDR report key: 743689 · Received June 1, 2005

    Report

    Report Number
    MW1035619
    Event Type
    Injury
    Date Received
    June 1, 2005
    Report Date
    May 23, 2005
    Manufacturer
    *
    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 2005, NOTED TO HAVE DEFLATION RIGHT BREAST IMPLANT. 1998, PT UNDERWENT BILATERAL SUBPECTORAL CONVERSION WITH SALINE IMPLANTS. IN 2005, PT UNDERWENT REMOVAL OF DEFLATED RIGHT BREAST IMPLANT. REPLACED WITH 270CC SALINE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP SALINE FILLED MEMMORY IMPLANT FWM * STYLE 168 HG 2454

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention