BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2042626 · Received April 1, 2011

    Report

    Report Number
    2042626
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RIGHT BREAST IMPLANT THAT WAS ORIGINALLY IMPLANTED IN 1999 DEFLATED AND WAS REMOVED EARLIER THIS YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SALINE BREAST IMPLANT FWM ALLERGAN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR