BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN NATRELLE SALINE BREAST IMPLANT

    MDR report key: 1709664 · Received May 22, 2010

    Report

    Report Number
    1709664
    Event Type
    Malfunction
    Date Received
    May 22, 2010
    Date of Event
    April 13, 2010
    Report Date
    May 19, 2010
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    LEFT BREAST IMPLANT EXCHANGE SECONDARY TO DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN NATRELLE SALINE BREAST IMPLANT SALINE BREAST IMPLANT FWM ALLERGAN 68MP 420 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR