BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN

    MDR report key: 1760784 · Received July 13, 2010

    Report

    Report Number
    MW5016736
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Date of Event
    May 6, 2010
    Report Date
    July 13, 2010
    Manufacturer
    ALLERGAN, INC.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN STATED PT HAD FALLEN AND RUPTURED LEFT BREAST IMPLANT. TODAY, BILATERAL BREAST IMPLANTS EXCHANGED. LEFT BREAST IMPLANT SENT TO LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN BREAST IMPLANT FWM ALLERGAN, INC. 120-650 CC 1738596

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR