BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN

    MDR report key: 489875 · Received October 1, 2003

    Report

    Report Number
    MW1029737
    Event Type
    Injury
    Date Received
    October 1, 2003
    Report Date
    September 23, 2003
    Manufacturer
    MCGHAN MED 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

    S/P BILATERAL MASTECTOMIES 8/1993 1994 - INSECTION 550 CC MCGHAN TEXTURED SALINE IMPLANTS. JAN 2002 - DEFLATED LEFT IMPLANT. 9-23-2003 PT UNDERWENT BILATERAL IMPLANT REMOVAL - RIGHT CAPSULECTOMY AND PLACEMENT OF SILICONE GEL IMPLANTS, 550 CC BY MENTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN TEXTURED SALINE IMPLANTS 550 CC FWM MCGHAN MED CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention