BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKER

    MDR report key: 1182785 · Received September 23, 2008

    Report

    Report Number
    1182785
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 23, 2008
    Manufacturer
    MENTOR CORPORATION
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PT HAD BILATERAL SALINE BREAST IMPLANTS PLACED 19 YEARS AGO. THEY WERE REMOVED BECAUSE THEY LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKER IMPLANT, BREAST FWM MENTOR CORPORATION UKN UKN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR