BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEFT BREAST PROSTHESIS

    MDR report key: 1250467 · Received December 2, 2008

    Report

    Report Number
    1250467
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    April 2, 2008
    Report Date
    November 26, 2008
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2005, THE PT UNDERWENT BILATERAL BREAST AUGMENTATION. IN 2008, THE PT RETURNED TO THE OR DUE TO DEFLATION OF THE LEFT BREAST PROSTHESIS. THE IMPLANT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEFT BREAST PROSTHESIS FWM UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention