BEUDAMED
    FDA Adverse Event Death Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 4046805 · Received August 26, 2014

    Report

    Report Number
    2024601-2014-00454
    Event Type
    Death
    Date Received
    August 26, 2014
    Date of Event
    January 13, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: 08/26/2014. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. IT IS UNLIKELY THE PRODUCT WILL BE RETURNED. DEATH IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    CLINICAL RESEARCH ORGANIZATION REPORTED THIS PT DIED ON (B)(6) 2014 OF UNK CAUSE. THIS FILE REPRESENTS THE LEFT SIDE DEVICE. SEE MFR 2024601-2014-00455 FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518298 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT FTR ALLERGAN NA 1691628

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death