BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGAN - ALLERGAN- BREAST IMPLANT

    MDR report key: 2982705 · Received February 22, 2013

    Report

    Report Number
    MW5029160
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MCGHAN/INAMED CORP
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT STATES SHE HAD BILATERAL MASTECTOMY WITH PLACEMENT OF SALINE BREAST IMPLANTS 18 YEARS AGO AT (B)(6) HOSPITAL. THE LEFT BREAST IMPLANT DEFLATED. TODAY PT HAD BILATERAL SALINE BREAST IMPLANTS REMOVED AND BILATERAL GEL-FILLED IMPLANTS IMPLANTED. SALINE IMPLANTS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78951 MCGAN - ALLERGAN- BREAST IMPLANT SALINE BREAST IMPLANT FWM MCGHAN/INAMED CORP 530 CC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR