BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH BECKER EXPANDER/MAMMARY PROSTHESIS

    MDR report key: 199410 · Received November 24, 1998

    Report

    Report Number
    1645337-1998-00259
    Event Type
    Injury
    Date Received
    November 24, 1998
    Report Date
    February 3, 1998
    Manufacturer
    MENTOR
    Product Code
    FTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BILATERALLY IMPLANTED WITH A SMOOTH BECKER EXPANDER/MAMMARY PROSTHESIS ON 04/25/1996. SUBSEQUENTLY, THE PT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND BREAST PAIN. THE DEVICES WERE REMOVED ON 06/19/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMOOTH BECKER EXPANDER/MAMMARY PROSTHESIS Implant EXPANDER/MAMMARY PROSTHESIS FTR MENTOR NA 47906

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention