BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMORYGEL MAMMARY PROSTHESIS

    MDR report key: 3082911 · Received April 22, 2013

    Report

    Report Number
    1645337-2013-00132
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A MENTOR MEMORYGEL DEVICE. SUBSEQUENTLY, ACCORDING TO THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED PAIN, FULLNESS IN THE LEFT SUPERIOR POLE, MISSHAPEN BREAST, CAPSULAR CONTRACTURE, WRINKLING AND SYMMASTIA. THE DEVICES HAVE BEEN REMOVED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172997 MEMORYGEL MAMMARY PROSTHESIS BREAST IMPLANT FTR MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other