BEUDAMED
    FDA Adverse Event Death Summary report: N

    STYLE 10 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 5488571 · Received March 9, 2016

    Report

    Report Number
    9617229-2016-00013
    Event Type
    Death
    Date Received
    March 9, 2016
    Date of Event
    January 5, 2009
    Report Date
    July 17, 2009
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF DEATH IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    PATIENT REPORTS HAVING BEEN DIAGNOSED WITH CANCER OF THE SMALL INTESTINE. SENIOR SAFETY SCIENTIST FROM (B)(4) REPORTED DEATH OF THE PATIENT. FOLLOW UP FINDINGS REVEALED THAT DEATH WAS DUE TO MALIGNANT NEOPLASM OF THE SMALL INTESTINE. FOLLOW UP IS PENDING CONCERNING THE CAUSALITY FOR THE EVENT OF CANCER AND ENDING IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144922 STYLE 10 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1509533

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death