BEUDAMED
    FDA Adverse Event Other Summary report: N

    MCGHAN MEDICAL

    MDR report key: 1192190 · Received October 7, 2008

    Report

    Report Number
    MW5008575
    Event Type
    Other
    Date Received
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    MCGHAN MEDICAL INAMED
    Product Code
    FWM
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AUGMENTATION 1990 WITH MCGHAN SALINE IMPLANTS. NOW DESIRES TO BE FULLER AND LARGER AND LIFTED. IN 2008, PT UNDERWENT BIL IMPLANT REMOVAL. BOTH IMPLANTS REMOVED IN TACT. AUGMENTED WITH MENTOR MOD AND GEL IMPLANTS 400CC RIGHT, 450CC LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL SALINE BREAST IMPLANTS, RIGHT FWM MCGHAN MEDICAL INAMED UNK UNK
    2 MCGHAN MEDICAL SALINE BREAST IMPLANTS, LEFT FWM MCGHAN MEDICAL INAMED UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other