BEUDAMED
    FDA Adverse Event Summary report: N

    MENTOR WORLDWIDE LLC

    MDR report key: 1847209 · Received September 21, 2010

    Report

    Report Number
    1645337-2010-00024
    Date Received
    September 21, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MENTOR WORLDWIDE LLC.
    Product Code
    FWM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SERIAL NUMBER: (B)(4).

    Description of Event or Problem · 1

    PT HAS REPORTED WEAKNESS, DIZZINESS AND WEIGHT LOSS (RHEUMATOLOGIST THINKS THERE MAY BE FUNGUS IN THE IMPLANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR WORLDWIDE LLC SALINE-FILLED MAMMARY PROSTHESES FWM MENTOR WORLDWIDE LLC. 5668754 (BILATERAL)

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other