BEUDAMED
    FDA Adverse Event Death Summary report: N

    STYLE 120 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 4251022 · Received November 5, 2014

    Report

    Report Number
    2024601-2014-00594
    Event Type
    Death
    Date Received
    November 5, 2014
    Date of Event
    December 2, 2013
    Report Date
    July 19, 2014
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABORATORY ANALYSIS: VISUAL ANALYSIS - WHITE PARTICLES NOTED; STANDARD ANALYSIS - DEFORMATION; MICROANALYSIS - NO OTHER OBSERVATIONS NOTED. REVIEW OF LABELING ADDRESS THE REPORTED EVENTS AS FOLLOWS: "POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH SILICONE GEL-FILLED BREAST IMPLANT SURGERY INCLUDE: IMPLANT RUPTURE, CAPSULAR CONTRACTURE, REOPERATION, IMPLANT REMOVAL...." (ALLERGAN SILICONE BREAST IMPLANT LABELING).

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED TO ALLERGAN REPRESENTATIVE A CASE OF A PATIENT WITH LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. RUPTURE AND EXPLANT OF DEVICES ALSO REPORTED ADDITIONAL REPORT OF DEATH RECEIVED WITH NO INFO REGARDING DATE OF CAUSE OF DEATH. DUE DILIGENCE HAS BEEN CARRIED OUT AND THIS INVESTIGATION HAS BEEN CONTINUED TO DATE. IF FURTHER INFO IS OBTAINED THIS WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710003 STYLE 120 SILICONE GEL FILLED BREAST IMPLANT FTR ALLERGAN NA 155635

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death| R