BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SALINE-FILLED BREAST IMPLANT

    MDR report key: 1853336 · Received October 1, 2010

    Report

    Report Number
    1645337-2010-00027
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    June 18, 2010
    Report Date
    September 30, 2010
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE ORIGINAL PURCHASE DATE OF THIS DEVICE WAS (B)(6)2004. IN (B)(6) 2006, THE PT WAS IMPLANTED WITH MENTOR SILTEX SALINE DEVICES DURING A REVISION AUGMENTATION PROCEDURE. IN (B)(6) 2008, THE DEVICES WERE REPLACED WITH MENTOR SMOOTH SALINE DEVICES DUE TO A LEFT DEVICE DEFLATION. IN (B)(6) 2010, THE PT HAD BOTH IMPLANTS REMOVED DUE TO RECURRING FLUID ACCUMULATION IN THE RIGHT BREAST. ON (B)(6)2010, THE PT WAS DIAGNOSED WITH ALCL (T-CELL LYMPHOMA). NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SALINE-FILLED BREAST IMPLANT BREAST IMPLANT FWM MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other