BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAST IMPLANT STYLE 330

    MDR report key: 1913118 · Received November 14, 2010

    Report

    Report Number
    1913118
    Event Type
    Malfunction
    Date Received
    November 14, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 14, 2010
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF LEFT RUPTURED SALINE IMPLANT WITH REPLACEMENT WITH INAMED STYLE 68-MODERATE PROFILE-330 ML IMPLANTS AND POSSIBLE CAPSULOTOMY AND CAPSULECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREAST IMPLANT STYLE 330 BREAST IMPLANT 330 FWM ALLERGAN NA 1029486

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR