BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX BECKER/EXPANDER MAMMARY PROSTHESIS

    MDR report key: 199398 · Received November 24, 1998

    Report

    Report Number
    1645337-1998-00255
    Event Type
    Injury
    Date Received
    November 24, 1998
    Date of Event
    March 1, 1997
    Report Date
    January 13, 1998
    Manufacturer
    MENTOR
    Product Code
    FTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A SILTEX BECKER EXPANDER/MAMMARY PROSTHESIS ON 1/13/1994. SUBSEQUENTLY, THE PT EXPERIENCED A RUPTURE OF THE DEVICE AND A SEROMA. THE DEVICE WAS REMOVED ON 3/13/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX BECKER/EXPANDER MAMMARY PROSTHESIS Implant EXPANDER/MAMMARY PROSTHESIS FTR MENTOR NA 84944

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention