BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFT BREAST SILICONE IMPLANT

    MDR report key: 1891772 · Received October 17, 2010

    Report

    Report Number
    1891772
    Event Type
    Malfunction
    Date Received
    October 17, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 17, 2010
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEFT BREAST RUPTURED IMPLANT AND CAPSULE, RIGHT BREAST CAPSULE.NEED FOR AN OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEFT BREAST SILICONE IMPLANT SILICONE BREAST IMPLANT BREAST FTR ALLERGAN 300CC *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR